LABELS · 1ff72539-1af5-41bf-8720-1ba12df35abc

Fluorouracil

Open original source → · Download preserved record

Preserved label snapshot, not confirmation of a current approved indication. Approval/withdrawal status must be checked for the exact disease, setting and regimen.

Label effective date: 2021-06-30
Captured: 2026-09-09T23:37:42.544548+00:00
Current indication reconciliation: Not reconciled

Indications and usage: exact source text

INDICATIONS AND USAGE Fluorouracil 5% Topical Cream is recommended for the topical treatment of multiple actinic or solar keratoses. In the 5% strength, it is also useful in the treatment of superficial basal cell carcinomas when conventional methods are impractical, such as with multiple lesions or difficult treatment sites. Safety and efficacy in other indications have not been established. The diagnosis should be established prior to treatment, since this method has not been proven effective in other types of basal cell carcinomas. With isolated, easily accessible basal cell carcinomas, surgery is preferred since success with such lesions is almost 100%. The success rate with Fluorouracil 5% Topical Cream is approximately 93%, based on 113 lesions in 54 patients. Twenty-five lesions treated with the solution produced 1 failure and 88 lesions treated with the cream produced 7 failures.

Full extracted label fields

application numbers

NDA016831

boxed warning exact

brand names

Fluorouracil

current indication status

not_reconciled

dailymed set url

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=744737c5-0d96-4214-82ab-6cff016b1ea0

generic names

FLUOROURACIL

1ff72539-1af5-41bf-8720-1ba12df35abc

indications and usage exact

INDICATIONS AND USAGE Fluorouracil 5% Topical Cream is recommended for the topical treatment of multiple actinic or solar keratoses. In the 5% strength, it is also useful in the treatment of superficial basal cell carcinomas when conventional methods are impractical, such as with multiple lesions or difficult treatment sites. Safety and efficacy in other indications have not been established. The diagnosis should be established prior to treatment, since this method has not been proven effective in other types of basal cell carcinomas. With isolated, easily accessible basal cell carcinomas, surgery is preferred since success with such lesions is almost 100%. The success rate with Fluorouracil 5% Topical Cream is approximately 93%, based on 113 lesions in 54 patients. Twenty-five lesions treated with the solution produced 1 failure and 88 lesions treated with the cream produced 7 failures.

indications and usage tables exact

is original packager

true

manufacturer names

Mylan Pharmaceuticals Inc.

matched search terms

carcinomas

package ndcs

0378-4791-06

product ndcs

0378-4791

product types

HUMAN PRESCRIPTION DRUG

recent major changes exact

record type

complete_spl_indications_section_candidate

routes

TOPICAL

rxcuis

source batch

file

/private/tmp/cancer-full-research/indications/raw/labels-00100.json

meta

disclaimer

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.

last updated

2026-09-09

license

https://open.fda.gov/license/

results

limit: 100
skip: 100
total: 830

terms

https://open.fda.gov/terms/

sha256

fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058

url

source url

https://api.fda.gov/drug/label.json?search=id%3A%221ff72539-1af5-41bf-8720-1ba12df35abc%22

spl effective date

2021-06-30

spl effective time

20210630

spl set id

744737c5-0d96-4214-82ab-6cff016b1ea0

spl version

substance names

FLUOROURACIL

uniis

U3P01618RT

verification flags

oncology_keyword_candidate_not_clinically_classified
spl_text_not_verified_identical_to_latest_approved_label
individual_indications_not_split_or_reconciled
fda_label_posted_after_spl_effective_date_requires_version_review

Drugs@FDA application source records

application number
NDA016831
payload
all indexed label documents
Appl No
016831
Application Docs Date
2005-10-19 00:00:00
Application Docs ID
10926
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/016831s049lbl.pdf
Submission No
49
Submission Type
SUPPL
Appl No
016831
Application Docs Date
2004-06-25 00:00:00
Application Docs ID
33201
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/16831slr047_efudex_lbl.pdf
Submission No
47
Submission Type
SUPPL
Appl No
016831
Application Docs Date
2021-10-25 00:00:00
Application Docs ID
68998
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/016831Orig1s063lbl.pdf
Submission No
63
Submission Type
SUPPL
all submission records
Appl No
016831
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
63
Submission Status
AP
Submission Status Date
2021-10-14 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
016831
Review Priority
STANDARD
Submission Class Code ID
4
Submission No
59
Submission Status
AP
Submission Status Date
2015-11-04 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
016831
Review Priority
STANDARD
Submission Class Code ID
4
Submission No
58
Submission Status
AP
Submission Status Date
2015-08-18 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
016831
Review Priority
STANDARD
Submission Class Code ID
4
Submission No
57
Submission Status
AP
Submission Status Date
2015-05-06 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
016831
Review Priority
STANDARD
Submission Class Code ID
4
Submission No
56
Submission Status
AP
Submission Status Date
2013-07-02 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
016831
Review Priority
STANDARD
Submission Class Code ID
4
Submission No
55
Submission Status
AP
Submission Status Date
2013-12-12 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
016831
Review Priority
N/A
Submission Class Code ID
4
Submission No
51
Submission Status
AP
Submission Status Date
2006-05-10 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
016831
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
49
Submission Status
AP
Submission Status Date
2005-10-13 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
016831
Review Priority
STANDARD
Submission Class Code ID
3
Submission No
47
Submission Status
AP
Submission Status Date
2004-06-24 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
016831
Review Priority
STANDARD
Submission Class Code ID
4
Submission No
46
Submission Status
AP
Submission Status Date
2004-04-27 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
016831
Review Priority
STANDARD
Submission Class Code ID
4
Submission No
43
Submission Status
AP
Submission Status Date
2002-11-27 00:00:00
Submission Type
SUPPL
Submissions Public Notes
Appl No
016831
Review Priority
STANDARD
Submission Class Code ID
4
Submission No
42
Submission Status
AP
Submission Status Date
2001-08-30 00:00:00
Submission Type
SUPPL
Submissions Public Notes
application number
NDA016831
approval interpretation
Application linkage and approved submission are not indication-level current approval verification
current indication status
not_reconciled
drugsfda url
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=016831
has approved submission record
true
latest approved submission date
2021-10-14
latest label selection rule
max FDA ApplicationDocsDate, including all ties; posting date is not approval date and latest indexed document may be incomplete
latest posted label documents
Appl No
016831
Application Docs Date
2021-10-25 00:00:00
Application Docs ID
68998
Application Docs Title
0
Application Docs Type ID
2
Application Docs URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/016831Orig1s063lbl.pdf
Submission No
63
Submission Type
SUPPL
official application record
Appl No
016831
Appl Public Notes
Appl Type
NDA
Sponsor Name
EXTROVIS
openfda application present
true
products
Active Ingredient
FLUOROURACIL
Appl No
016831
Drug Name
EFUDEX
Form
SOLUTION;TOPICAL
Product No
001
Reference Drug
1
Reference Standard
1
Strength
2%
marketing status
Prescription
Active Ingredient
FLUOROURACIL
Appl No
016831
Drug Name
EFUDEX
Form
SOLUTION;TOPICAL
Product No
002
Reference Drug
1
Reference Standard
0
Strength
5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
marketing status
Discontinued
Active Ingredient
FLUOROURACIL
Appl No
016831
Drug Name
EFUDEX
Form
CREAM;TOPICAL
Product No
003
Reference Drug
1
Reference Standard
1
Strength
5%
marketing status
Prescription

Source passages and status connections

Passage classifications are automated and are not treatment recommendations. Connections apply only to their recorded indication scope.

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use intent

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Passage 3 · limitation of use

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exact text: The success rate with Fluorouracil 5% Topical Cream is approximately 93%, based on 113 lesions in 54 patients.
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offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 5ea40d7c4c9fa584f7887b5869c6ab8b13bf6b0a21ae4e8610de70bbac95834a
start: 666

source url

https://api.fda.gov/drug/label.json?search=id%3A%221ff72539-1af5-41bf-8720-1ba12df35abc%22

spl effective date

2021-06-30

spl set id

744737c5-0d96-4214-82ab-6cff016b1ea0

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

unclear

Passage 7 · unclassified context

application numbers

NDA016831

brand names

Fluorouracil

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 900
end exclusive: true
exact text: al cell carcinomas, surgery is preferred since success with such lesions is almost 100%. The success rate with Fluorouracil 5% Topical Cream is approximately 93%, based on 113 lesions in 54 patients. Twenty-five lesions treated with the solution produced 1 failure and 88 lesions treated with the cream produced 7 failures.
label id: 1ff72539-1af5-41bf-8720-1ba12df35abc
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 5ea40d7c4c9fa584f7887b5869c6ab8b13bf6b0a21ae4e8610de70bbac95834a
start: 577

current approval status

not_reconciled

duplicate text group

dup-fd33e4063330b37ce7dd

extraction review status

automated_candidate_pending_source_review

generic names

FLUOROURACIL

ind-span-b7929de6a86551adedf5

label id

1ff72539-1af5-41bf-8720-1ba12df35abc

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058

source defined aliases

source span

end: 900
end exclusive: true
exact text: Twenty-five lesions treated with the solution produced 1 failure and 88 lesions treated with the cream produced 7 failures.
label id: 1ff72539-1af5-41bf-8720-1ba12df35abc
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 5ea40d7c4c9fa584f7887b5869c6ab8b13bf6b0a21ae4e8610de70bbac95834a
start: 777

source url

https://api.fda.gov/drug/label.json?search=id%3A%221ff72539-1af5-41bf-8720-1ba12df35abc%22

spl effective date

2021-06-30

spl set id

744737c5-0d96-4214-82ab-6cff016b1ea0

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

unclear

Preserved source evidence · Not medical advice