Efudex

Product NDC: 0187-3204
11-digit product format: 001873204
Labeler code: 0187
Product ID: 0187-3204_3375c5f7-9b6f-8ca1-e063-6394a90aaff8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fluorouracil
Dosage form: CREAM
Route: TOPICAL
Labeler: Bausch Health US, LLC
Application: NDA016831
Marketing category: NDA
Marketing start: 1970-07-29
Substance: FLUOROURACIL
Active strength: 2 g/40g
Pharmacologic classes: Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 14 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0187-3204-47	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0187-3204-47	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0187-3204-47	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0187-3204-47	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0187-3204-47	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0187-3204-47	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0187-3204-47	`0efc9e666f02…`	`f202fb6c5f17…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS
N016831-001	EFUDEX	FLUOROURACIL	2%	SOLUTION / TOPICAL	AT	RLD, RS, Approved before 1982
N016831-002	EFUDEX	FLUOROURACIL	5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / TOPICAL		RLD, Approved before 1982
N016831-003	EFUDEX	FLUOROURACIL	5%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
N016831-001	AT
N016831-003	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2026-08-18 06:07:40	2026-07	N016831-001	EFUDEX	2%	SOLUTION / TOPICAL	AT	RLD, RS, Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N016831-002	EFUDEX	5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / TOPICAL		RLD, Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N016831-003	EFUDEX	5%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N016831-001	EFUDEX	2%	SOLUTION / TOPICAL	AT	RLD, RS, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N016831-002	EFUDEX	5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / TOPICAL		RLD, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N016831-003	EFUDEX	5%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N016831-001	EFUDEX	2%	SOLUTION / TOPICAL	AT	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N016831-002	EFUDEX	5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / TOPICAL		RLD, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N016831-003	EFUDEX	5%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N016831-001	EFUDEX	2%	SOLUTION / TOPICAL	AT	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N016831-002	EFUDEX	5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / TOPICAL		RLD, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N016831-003	EFUDEX	5%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N016831-001	EFUDEX	2%	SOLUTION / TOPICAL	AT	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N016831-002	EFUDEX	5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / TOPICAL		RLD, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N016831-003	EFUDEX	5%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N016831-001	EFUDEX	2%	SOLUTION / TOPICAL	AT	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N016831-002	EFUDEX	5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / TOPICAL		RLD, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N016831-003	EFUDEX	5%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N016831-001	EFUDEX	2%	SOLUTION / TOPICAL	AT	RLD, RS, Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N016831-002	EFUDEX	5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / TOPICAL		RLD, Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N016831-003	EFUDEX	5%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N016831-001	EFUDEX	2%	SOLUTION / TOPICAL	AT	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N016831-002	EFUDEX	5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / TOPICAL		RLD, Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N016831-003	EFUDEX	5%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N016831-001	EFUDEX	2%	SOLUTION / TOPICAL	AT	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N016831-002	EFUDEX	5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / TOPICAL		RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N016831-003	EFUDEX	5%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N016831-001	EFUDEX	2%	SOLUTION / TOPICAL	AT	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N016831-002	EFUDEX	5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / TOPICAL		RLD, Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N016831-003	EFUDEX	5%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N016831-001	EFUDEX	2%	SOLUTION / TOPICAL	AT	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N016831-002	EFUDEX	5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / TOPICAL		RLD, Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N016831-003	EFUDEX	5%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N016831-001	EFUDEX	2%	SOLUTION / TOPICAL	AT	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N016831-002	EFUDEX	5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / TOPICAL		RLD, Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N016831-003	EFUDEX	5%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N016831-001	EFUDEX	2%	SOLUTION / TOPICAL	AT	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N016831-002	EFUDEX	5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / TOPICAL		RLD, Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N016831-003	EFUDEX	5%	CREAM / TOPICAL	AB	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N016831-001	EFUDEX	2%	SOLUTION / TOPICAL	AT	RLD, RS, Approved before 1982	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N016831-001	AT	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N016831-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N016831-001	AT	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N016831-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N016831-001	AT	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N016831-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N016831-001	AT	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N016831-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N016831-001	AT	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N016831-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N016831-001	AT	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N016831-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N016831-001	AT	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N016831-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N016831-001	AT	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N016831-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N016831-001	AT	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N016831-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N016831-001	AT	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N016831-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N016831-001	AT	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N016831-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N016831-001	AT	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N016831-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N016831-001	AT	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N016831-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N016831-001	AT	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N016831-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N016831-001	AT	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N016831-003	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N016831-001	AT	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N016831-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N016831-001	AT	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N016831-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N016831-001	AT	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N016831-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N016831-001	AT	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N016831-002	AT	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N016831-003	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N016831-001	AT	1	`bb7c543d1eb4…`

Additional Listing Data#

Finished product: Yes
Brand name base: Efudex
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
FLUOROURACIL	2 g/40g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
U3P01618RT	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
105583	Internal RxNorm lookup
213045	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
35de1c1c-bef5-46c5-b6f8-ea032147411c	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
77dc03a4-fbfc-e6a3-fe95-285bbae40d75	Product name	2	20250814
7dc9482d-9b87-4471-9708-4f1b4585846b	Product name	2	20250723
a2ca0bf8-8306-49cc-93a3-3e6e4137c7cb	Product name	5	20250630
dc0d2364-4811-4665-a3ee-7ed8c7301465	Product name	2	20171219
62fb8671-1693-49d8-8aab-0c1bfdd6794e	Product name	1	20151005
878ca466-81fd-9d24-1349-31baf36065c6	Product name	2	20150506
630d1bc2-ae6b-fd31-1264-c4733e788193	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0187-3204-47	Efudex	40 g in 1 TUBE	CREAM	40		20
0187-3204-47	Efudex	1 in 1 CARTON	CREAM	1		20

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0187-3204-47	GM - Gram	0187-3204	487aa36e-8675-45a2-baae-8a388dc165d3	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Fluorouracil	ACTIVE INGREDIENT	U3P01618RT	EFUDEX (FLUOROURACIL) SOLUTION EFUDEX (FLUOROURACIL) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	3
Fluorouracil	ACTIVE MOIETY	U3P01618RT	EFUDEX (FLUOROURACIL) SOLUTION EFUDEX (FLUOROURACIL) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	3
edetate disodium	INACTIVE INGREDIENT	7FLD91C86K	EFUDEX (FLUOROURACIL) SOLUTION EFUDEX (FLUOROURACIL) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	3
hydroxypropyl cellulose	INACTIVE INGREDIENT	RFW2ET671P	EFUDEX (FLUOROURACIL) SOLUTION EFUDEX (FLUOROURACIL) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	3
methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	EFUDEX (FLUOROURACIL) SOLUTION EFUDEX (FLUOROURACIL) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	3
petrolatum	INACTIVE INGREDIENT	4T6H12BN9U	EFUDEX (FLUOROURACIL) SOLUTION EFUDEX (FLUOROURACIL) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	3
polysorbate 60	INACTIVE INGREDIENT	CAL22UVI4M	EFUDEX (FLUOROURACIL) SOLUTION EFUDEX (FLUOROURACIL) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	3
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	EFUDEX (FLUOROURACIL) SOLUTION EFUDEX (FLUOROURACIL) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	3
propylparaben	INACTIVE INGREDIENT	Z8IX2SC1OH	EFUDEX (FLUOROURACIL) SOLUTION EFUDEX (FLUOROURACIL) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	3
stearyl alcohol	INACTIVE INGREDIENT	2KR89I4H1Y	EFUDEX (FLUOROURACIL) SOLUTION EFUDEX (FLUOROURACIL) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	3
Tromethamine	INACTIVE INGREDIENT	023C2WHX2V	EFUDEX (FLUOROURACIL) SOLUTION EFUDEX (FLUOROURACIL) CREAM [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0187-3204	EFUDEX (FLUOROURACIL) SOLUTION EFUDEX (FLUOROURACIL) CREAM [BAUSCH HEALTH US, LLC]	20	Current NDC, Legacy NDC, 2 package rows	20250425_35de1c1c-bef5-46c5-b6f8-ea032147411c.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Efudex	FLUOROURACIL	Bausch Health US, LLC	35de1c1c-bef5-46c5-b6f8-ea032147411c	2025-04-23		Exact identifier application applno (NDA): 016831 application number: NDA016831 ndc (product): 0187-3204
Fluorouracil	FLUOROURACIL	Mylan Pharmaceuticals Inc.	744737c5-0d96-4214-82ab-6cff016b1ea0	2021-06-30	Warnings, Adverse reactions	Exact identifier application applno (NDA): 016831 application number: NDA016831

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
U3P01618RT	FLUOROURACIL	51-21-8	FLUOROURACIL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
213045	Efudex 5 % Topical Cream	PSN	35de1c1c-bef5-46c5-b6f8-ea032147411c	20
105583	fluorouracil 5 % Topical Cream	PSN	35de1c1c-bef5-46c5-b6f8-ea032147411c	20
213045	fluorouracil 50 MG/ML Topical Cream [Efudex]	SBD	35de1c1c-bef5-46c5-b6f8-ea032147411c	20
105583	fluorouracil 50 MG/ML Topical Cream	SCD	35de1c1c-bef5-46c5-b6f8-ea032147411c	20
105583	5-5-fluorouracil 50 MG/ML Topical Cream	SY	35de1c1c-bef5-46c5-b6f8-ea032147411c	20
213045	5-5-fluorouracil 50 MG/ML Topical Cream [Efudex]	SY	35de1c1c-bef5-46c5-b6f8-ea032147411c	20
105583	5-FU 50 MG/ML Topical Cream	SY	35de1c1c-bef5-46c5-b6f8-ea032147411c	20
213045	5-FU 50 MG/ML Topical Cream [Efudex]	SY	35de1c1c-bef5-46c5-b6f8-ea032147411c	20
213045	Efudex 5 % Topical Cream	SY	35de1c1c-bef5-46c5-b6f8-ea032147411c	20
213045	Efudex 50 MG/ML Topical Cream	SY	35de1c1c-bef5-46c5-b6f8-ea032147411c	20
105583	fluorouracil 5 % Topical Cream	SY	35de1c1c-bef5-46c5-b6f8-ea032147411c	20

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0187-3204-47	00187320447	1 TUBE in 1 CARTON (0187-3204-47) / 40 g in 1 TUBE	1 tube	1970-07-29	2026-09-30	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Efudex	Bausch Health US, LLC \| Bausch Health Companies Inc. \| Kavis Pharma LLC	2025-04-23	HUMAN PRESCRIPTION DRUG LABEL	20