Lotrimin Ultra

Manufacturer: Bayer Healthcare LLC.
Effective date: 2025-12-05
Label type: HUMAN OTC DRUG LABEL
Version: 11
Source: full-release
Hydrated at: 2026-06-01 01:20:28

Label at a glance#

ProductLotrimin Ultra Athletes Foot

Active ingredientBUTENAFINE HYDROCHLORIDE

Label structure10 sections

Indications and uses

cures most athlete's foot between the toes. Effectiveness on the bottom or sides of foot is unknown. cures most jock itch and ringworm relieves itching, burning, cracking, and scaling which accompany these conditions

Dosage and administration

adults and children 12 years and older: use the tip of the cap to break the seal and open the tube wash the affected skin with soap and water and dry completely before applying for athlete's foot between the toes : apply to affected skin between and around the toes twice a day for 1 week (morning and night), or once a day for 4 weeks, or as directed by a doctor. Wear well-fitting, ventilated shoes. Change shoes an...

Storage and handling

do not use if seal on tube is broken or not visible store between 20° to 25°C (68° to 77°F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Butenafine hydrochloride 1%

Purpose

OTC - PURPOSE SECTION

Antifungal

Uses

INDICATIONS & USAGE SECTION

cures most athlete's foot between the toes. Effectiveness on the bottom or sides of foot is unknown.
cures most jock itch and ringworm
relieves itching, burning, cracking, and scaling which accompany these conditions

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

on nails or scalp
in or near the mouth or the eyes
for vaginal yeast infections

OTC - WHEN USING SECTION

When using this product do not get into the eyes. If eye contact occurs, rinse thoroughly with water.

OTC - STOP USE SECTION

Stop use and ask a doctor if too much irritation occurs or irritation gets worse

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children 12 years and older:
- use the tip of the cap to break the seal and open the tube
- wash the affected skin with soap and water and dry completely before applying
- for athlete's foot between the toes: apply to affected skin between and around the toes twice a day for 1 week (morning and night), or once a day for 4 weeks, or as directed by a doctor. Wear well-fitting, ventilated shoes. Change shoes and socks at least once daily.
- for jock itch and ringworm: apply once a day to affected skin for 2 weeks or as directed by a doctor
- wash hands after each use
children under 12 years: ask a doctor

Other information

STORAGE AND HANDLING SECTION

do not use if seal on tube is broken or not visible
store between 20° to 25°C (68° to 77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

benzyl alcohol, cetyl alcohol, glycerin, glyceryl monostearate SE, polyoxyethylene (23) cetyl ether, propylene glycol dicaprylate, purified water, sodium benzoate, stearic acid, trolamine, white petrolatum

SPL UNCLASSIFIED SECTION

Distributed by Bayer HealthCare LLC, Whippany, NJ 07981

PRINCIPAL DISPLAY PANEL - 12 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOTRIMIN ULTRA ®

butenafine hydrochloride cream 1%

ANTIFUNGAL

NET WT 12g (0.42 OZ)

Lotrimin Ultra AF 4338

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1298448	butenafine HCl 1 % Topical Cream	PSN	11
1298448	butenafine hydrochloride 10 MG/ML Topical Cream	SCD	11
1298448	butenafine HCl 1 % Topical Cream	SY	11

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
BUTENAFINE Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Barcode	EAN-13	0000000000000	GTIN-13: 0000000000000 EAN-13: 0000000000000 GTIN-12: 000000000000 UPC-A: 000000000000 GTIN storage (14 digits): 00000000000000	Lotrimin Ultra AF_4338.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
11523-4338-1	Lotrimin UltraAthletes Foot	12 g in 1 TUBE	CREAM	12	11
11523-4338-1	Lotrimin UltraAthletes Foot	1 in 1 CARTON	CREAM	1	11
11523-4338-2	Lotrimin UltraAthletes Foot	15 g in 1 TUBE	CREAM	15	11
11523-4338-2	Lotrimin UltraAthletes Foot	1 in 1 CARTON	CREAM	1	11
11523-4338-4	Lotrimin UltraAthletes Foot	1 in 1 CARTON	CREAM	1	11
11523-4338-4	Lotrimin UltraAthletes Foot	30 g in 1 TUBE	CREAM	30	11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
11523-4338-1	GM - Gram	11523-4338	7b97e907-4d14-497b-8e98-b327a4d20306	1	2017-07-07
11523-4338-4	GM - Gram	11523-4338	0fa093bf-8849-46d8-a07e-444260ebd6a0	1	2016-04-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Butenafine hydrochloride	ACTIVE INGREDIENT	R8XA2029ZI	1
Butenafine	ACTIVE MOIETY	91Y494NL0X	1
benzyl alcohol	INACTIVE INGREDIENT	LKG8494WBH	1
ceteth-23	INACTIVE INGREDIENT	495CTZ441V	1
cetyl alcohol	INACTIVE INGREDIENT	936JST6JCN	1
glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	1
petrolatum	INACTIVE INGREDIENT	4T6H12BN9U	1
propylene glycol dicaprylate	INACTIVE INGREDIENT	581437HWX2	1
sodium benzoate	INACTIVE INGREDIENT	OJ245FE5EU	1
stearic acid	INACTIVE INGREDIENT	4ELV7Z65AP	1
trolamine	INACTIVE INGREDIENT	9O3K93S3TK	1
water	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

Lotrimin Ultra Athletes Foot
Butenafine hydrochloride
CETYL ALCOHOL
GLYCERIN
CETETH-23
PROPYLENE GLYCOL DICAPRYLATE
WATER
SODIUM BENZOATE
STEARIC ACID
TROLAMINE
BENZYL ALCOHOL
BUTENAFINE
PETROLATUM

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
11523-4338	11523-4338-1, 11523-4338-2, 11523-4338-4

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
CETYL ALCOHOL	936JST6JCN	IACT
GLYCERIN	PDC6A3C0OX	IACT
CETETH-23	495CTZ441V	IACT
PROPYLENE GLYCOL DICAPRYLATE	581437HWX2	IACT
WATER	059QF0KO0R	IACT
SODIUM BENZOATE	OJ245FE5EU	IACT
STEARIC ACID	4ELV7Z65AP	IACT
TROLAMINE	9O3K93S3TK	IACT
BENZYL ALCOHOL	LKG8494WBH	IACT
BUTENAFINE HYDROCHLORIDE	R8XA2029ZI	ACTIB
PETROLATUM	4T6H12BN9U	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 36 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
propylene glycol dicaprylate	PROPYLENE GLYCOL DICAPRYLATE	581437HWX2	CREAM / TOPICAL	10 %w/w		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
sodium benzoate	SODIUM BENZOATE	OJ245FE5EU	CREAM / TOPICAL	0.2 %w/w		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
ceteth-23	CETETH-23	495CTZ441V	CREAM / TOPICAL	2 %w/w		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
petrolatum	PETROLATUM	4T6H12BN9U	CREAM / TOPICAL		4213 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
trolamine	TROLAMINE	9O3K93S3TK	CREAM / TOPICAL	1 %w/w		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
trolamine	TROLAMINE	9O3K93S3TK	CREAM / TOPICAL	1 %w/w		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
stearic acid	STEARIC ACID	4ELV7Z65AP	CREAM / TOPICAL		190 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
sodium benzoate	SODIUM BENZOATE	OJ245FE5EU	CREAM / TOPICAL	0.2 %w/w		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
stearic acid	STEARIC ACID	4ELV7Z65AP	CREAM / TOPICAL		190 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
propylene glycol dicaprylate	PROPYLENE GLYCOL DICAPRYLATE	581437HWX2	CREAM / TOPICAL	10 %w/w		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
ceteth-23	CETETH-23	495CTZ441V	CREAM / TOPICAL	2 %w/w		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	CREAM / TOPICAL		1720 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
cetyl alcohol	CETYL ALCOHOL	936JST6JCN	CREAM / TOPICAL		1280 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	CREAM / TOPICAL		1720 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
stearic acid	STEARIC ACID	4ELV7Z65AP	CREAM / TOPICAL		190 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
benzyl alcohol	BENZYL ALCOHOL	LKG8494WBH	CREAM / TOPICAL		160 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
petrolatum	PETROLATUM	4T6H12BN9U	CREAM / TOPICAL		4213 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
propylene glycol dicaprylate	PROPYLENE GLYCOL DICAPRYLATE	581437HWX2	CREAM / TOPICAL	10 %w/w		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
ceteth-23	CETETH-23	495CTZ441V	CREAM / TOPICAL	2 %w/w		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
benzyl alcohol	BENZYL ALCOHOL	LKG8494WBH	CREAM / TOPICAL		160 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
benzyl alcohol	BENZYL ALCOHOL	LKG8494WBH	CREAM / TOPICAL		160 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
propylene glycol dicaprylate	PROPYLENE GLYCOL DICAPRYLATE	581437HWX2	CREAM / TOPICAL	10 %w/w		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
petrolatum	PETROLATUM	4T6H12BN9U	CREAM / TOPICAL		4213 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
sodium benzoate	SODIUM BENZOATE	OJ245FE5EU	CREAM / TOPICAL	0.2 %w/w		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
benzyl alcohol	BENZYL ALCOHOL	LKG8494WBH	CREAM / TOPICAL		160 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
cetyl alcohol	CETYL ALCOHOL	936JST6JCN	CREAM / TOPICAL		1280 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
trolamine	TROLAMINE	9O3K93S3TK	CREAM / TOPICAL	1 %w/w		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
sodium benzoate	SODIUM BENZOATE	OJ245FE5EU	CREAM / TOPICAL	0.2 %w/w		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
ceteth-23	CETETH-23	495CTZ441V	CREAM / TOPICAL	2 %w/w		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
stearic acid	STEARIC ACID	4ELV7Z65AP	CREAM / TOPICAL		190 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	CREAM / TOPICAL		1720 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
cetyl alcohol	CETYL ALCOHOL	936JST6JCN	CREAM / TOPICAL		1280 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
petrolatum	PETROLATUM	4T6H12BN9U	CREAM / TOPICAL		4213 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
cetyl alcohol	CETYL ALCOHOL	936JST6JCN	CREAM / TOPICAL		1280 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	CREAM / TOPICAL		1720 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
trolamine	TROLAMINE	9O3K93S3TK	CREAM / TOPICAL	1 %w/w		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021307-001	LOTRIMIN ULTRA	BUTENAFINE HYDROCHLORIDE	1%	CREAM / TOPICAL		RLD, RS	2001-12-07

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 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	N021307-001	LOTRIMIN ULTRA	1%	CREAM / TOPICAL	RLD, RS	2001-12-07	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N021307-001	LOTRIMIN ULTRA	1%	CREAM / TOPICAL	RLD, RS	2001-12-07	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021307-001	LOTRIMIN ULTRA	1%	CREAM / TOPICAL	RLD, RS	2001-12-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021307-001	LOTRIMIN ULTRA	1%	CREAM / TOPICAL	RLD, RS	2001-12-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021307-001	LOTRIMIN ULTRA	1%	CREAM / TOPICAL	RLD, RS	2001-12-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021307-001	LOTRIMIN ULTRA	1%	CREAM / TOPICAL	RLD, RS	2001-12-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021307-001	LOTRIMIN ULTRA	1%	CREAM / TOPICAL	RLD, RS	2001-12-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021307-001	LOTRIMIN ULTRA	1%	CREAM / TOPICAL	RLD, RS	2001-12-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021307-001	LOTRIMIN ULTRA	1%	CREAM / TOPICAL	RLD, RS	2001-12-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021307-001	LOTRIMIN ULTRA	1%	CREAM / TOPICAL	RLD, RS	2001-12-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021307-001	LOTRIMIN ULTRA	1%	CREAM / TOPICAL	RLD, RS	2001-12-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021307-001	LOTRIMIN ULTRA	1%	CREAM / TOPICAL	RLD, RS	2001-12-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021307-001	LOTRIMIN ULTRA	1%	CREAM / TOPICAL	RLD, RS	2001-12-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021307-001	LOTRIMIN ULTRA	1%	CREAM / TOPICAL	RLD, RS	2001-12-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021307-001	LOTRIMIN ULTRA	1%	CREAM / TOPICAL	RLD, RS	2001-12-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021307-001	LOTRIMIN ULTRA	1%	CREAM / TOPICAL	RLD, RS	2001-12-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021307-001	LOTRIMIN ULTRA	1%	CREAM / TOPICAL	RLD, RS	2001-12-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021307-001	LOTRIMIN ULTRA	1%	CREAM / TOPICAL	RLD, RS	2001-12-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021307-001	LOTRIMIN ULTRA	1%	CREAM / TOPICAL	RLD, RS	2001-12-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021307-001	LOTRIMIN ULTRA	1%	CREAM / TOPICAL	RLD, RS	2001-12-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021307-001	LOTRIMIN ULTRA	1%	CREAM / TOPICAL	RLD, RS	2001-12-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021307-001	LOTRIMIN ULTRA	1%	CREAM / TOPICAL	RLD, RS	2001-12-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021307-001	LOTRIMIN ULTRA	1%	CREAM / TOPICAL	RLD, RS	2001-12-07	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021307-001	LOTRIMIN ULTRA	1%	CREAM / TOPICAL	RLD, RS	2001-12-07	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021307-001	LOTRIMIN ULTRA	1%	CREAM / TOPICAL	RLD, RS	2001-12-07	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021307-001	LOTRIMIN ULTRA	1%	CREAM / TOPICAL	RLD, RS	2001-12-07	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021307-001	LOTRIMIN ULTRA	1%	CREAM / TOPICAL	RLD, RS	2001-12-07	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021307-001	LOTRIMIN ULTRA	1%	CREAM / TOPICAL	RLD, RS	2001-12-07	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021307-001	LOTRIMIN ULTRA	1%	CREAM / TOPICAL	RLD, RS	2001-12-07	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021307-001	LOTRIMIN ULTRA	1%	CREAM / TOPICAL	RLD, RS	2001-12-07	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021307-001	LOTRIMIN ULTRA	1%	CREAM / TOPICAL	RLD, RS	2001-12-07	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021307-001	LOTRIMIN ULTRA	1%	CREAM / TOPICAL	RLD, RS	2001-12-07	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021307-001	LOTRIMIN ULTRA	1%	CREAM / TOPICAL	RLD, RS	2001-12-07	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021307-001	LOTRIMIN ULTRA	1%	CREAM / TOPICAL	RLD, RS	2001-12-07	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021307-001	LOTRIMIN ULTRA	1%	CREAM / TOPICAL	RLD, RS	2001-12-07	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021307-001	LOTRIMIN ULTRA	1%	CREAM / TOPICAL	RLD, RS	2001-12-07	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021307-001	LOTRIMIN ULTRA	1%	CREAM / TOPICAL	RLD, RS	2001-12-07	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021307-001	LOTRIMIN ULTRA	1%	CREAM / TOPICAL	RLD, RS	2001-12-07	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021307-001	LOTRIMIN ULTRA	1%	CREAM / TOPICAL	RLD, RS	2001-12-07	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021307-001	LOTRIMIN ULTRA	1%	CREAM / TOPICAL	RLD, RS	2001-12-07	`3a93d1ddd44b…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lotrimin Ultra Athletes Foot	BUTENAFINE HYDROCHLORIDE	Bayer Healthcare LLC.	e258c4ac-53ef-4a99-b732-4985f890b938	2025-12-05	Warnings	Exact identifier ndc (package): 11523-4338-2 ndc (package): 11523-4338-1 ndc (package): 11523-4338-4 ndc (product): 11523-4338 ndc11 (package): 11523433801 ndc11 (package): 11523433802 ndc11 (package): 11523433804 spl id: 45370c88-0d4f-d4df-e063-6394a90a6eb7 spl set id: e258c4ac-53ef-4a99-b732-4985f890b938

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.