Banophen

Product NDC: 0904-5354
11-digit product format: 009045354
Labeler code: 0904
Product ID: 0904-5354_9d9d4074-238a-49d0-a5ef-39414da07434
Type: HUMAN OTC DRUG
Nonproprietary name: Diphenhydramine Hydrochloride, Zinc Acetate
Dosage form: CREAM
Route: TOPICAL
Labeler: Major Pharmaceuticals
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2009-06-19
Substance: DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE
Active strength: 2; .1 g/100g; g/100g
Pharmacologic classes: Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Banophen
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DIPHENHYDRAMINE HYDROCHLORIDE	2 g/100g
ZINC ACETATE	.1 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
TC2D6JAD40	Internal UNII lookup
FM5526K07A	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1087026	Internal RxNorm lookup
1092428	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
9758d886-bd58-4eb2-a827-fa8e7fee2b7c	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f47a510b-6679-4664-b2d6-47b5c4afe7cc	Product name	4	20260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61c	Product name	2	20250515
0e2e0f88-b076-afe1-4bdd-32bca4375bec	Product name	3	20250127
0306390c-dd77-4363-afe0-63c58088b2a1	Product name	1	20220120
503ea967-4b9c-48cf-9e87-c7975295849d	Product name	2	20220120
190f2a5b-bbc8-65c7-fcb0-97891307b917	Product name	1	20140508
3e48c9c4-918d-5d23-2f0b-d2398b06be54	Product name	1	20140508
865c72dd-0d94-daac-f728-ddd4ded2a79e	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0904-5354-31	Banophen	1 in 1 CARTON	CREAM	1		5
0904-5354-31	Banophen	28 g in 1 TUBE	CREAM	28		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0904-5354-31	GM - Gram	0904-5354	6a476b0d-917c-4d7b-9b92-2d7e56108466	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DIPHENHYDRAMINE HYDROCHLORIDE	ACTIVE INGREDIENT	TC2D6JAD40	DIPHENHYDRAMINE (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [PHYSICIANS TOTAL CARE, INC.]	1
DIPHENHYDRAMINE HYDROCHLORIDE	ACTIVE INGREDIENT	TC2D6JAD40	BANOPHEN (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [MAJOR PHARMACEUTICALS]	1
ZINC ACETATE	ACTIVE INGREDIENT	FM5526K07A	DIPHENHYDRAMINE (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [PHYSICIANS TOTAL CARE, INC.]	1
ZINC ACETATE	ACTIVE INGREDIENT	FM5526K07A	BANOPHEN (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [MAJOR PHARMACEUTICALS]	1
DIPHENHYDRAMINE	ACTIVE MOIETY	8GTS82S83M	DIPHENHYDRAMINE (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [PHYSICIANS TOTAL CARE, INC.]	1
DIPHENHYDRAMINE	ACTIVE MOIETY	8GTS82S83M	BANOPHEN (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [MAJOR PHARMACEUTICALS]	1
ZINC	ACTIVE MOIETY	J41CSQ7QDS	DIPHENHYDRAMINE (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [PHYSICIANS TOTAL CARE, INC.]	1
ZINC	ACTIVE MOIETY	J41CSQ7QDS	BANOPHEN (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [MAJOR PHARMACEUTICALS]	1
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	DIPHENHYDRAMINE (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [PHYSICIANS TOTAL CARE, INC.]	1
DIAZOLIDINYL UREA	INACTIVE INGREDIENT	H5RIZ3MPW4	DIPHENHYDRAMINE (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [PHYSICIANS TOTAL CARE, INC.]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	DIPHENHYDRAMINE (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [PHYSICIANS TOTAL CARE, INC.]	1
PEG-2 STEARATE	INACTIVE INGREDIENT	94YQ11Y95F	DIPHENHYDRAMINE (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [PHYSICIANS TOTAL CARE, INC.]	1
PEG-20 STEARATE	INACTIVE INGREDIENT	NBX892EA57	DIPHENHYDRAMINE (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [PHYSICIANS TOTAL CARE, INC.]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	DIPHENHYDRAMINE (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [PHYSICIANS TOTAL CARE, INC.]	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	DIPHENHYDRAMINE (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [PHYSICIANS TOTAL CARE, INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	DIPHENHYDRAMINE (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [PHYSICIANS TOTAL CARE, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0904-5354	BANOPHEN (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [MAJOR PHARMACEUTICALS]	4	Current NDC, Legacy NDC, 2 package rows	20240926_9758d886-bd58-4eb2-a827-fa8e7fee2b7c.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 52 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Blue-Emu THRIVE Cooling	TRIPELENNAMINE 0.5%	Kingsway Pharmaceuticals dba NFI, LLC	7ac6456a-42c5-4ac8-aae6-db4abfda9df0	2025-12-22	Warnings	Exact identifier application number: M017
MENTHOL	MENTHOL	SUNSET PAIN RELIEF	45c5ca6f-d425-6cfb-e063-6394a90a1b66	2025-12-20	Warnings	Exact identifier application number: M017
HERSTAT GST Genital Sore Treatment	CAMPHOR, MENTHOL	Herstat (USA) Inc.	e8d27684-fb15-2e6a-e053-2a95a90a248f	2025-12-19	Warnings	Exact identifier application number: M017
Kroger Anti Itch	HYDROCORTISONE	The Kroger Co	46547277-f11a-b9e7-e063-6294a90a2ccd	2025-12-19	Warnings	Exact identifier application number: M017
Kroger Cool and Heat Roll-On	MENTHOL	Kroger	46551d07-3006-c3ec-e063-6294a90aa3f2	2025-12-19	Warnings	Exact identifier application number: M017
Naughty Kitty Kat	NO GAG DEEP THROAT SPRAY	INKED SUGAR, INC	170eb644-c72c-5744-e063-6394a90a767d	2025-12-19	Warnings	Exact identifier application number: M017
Tiger Balm Red Extra Strength	CAMPHOR (SYNTHETIC) AND MENTHOL	Haw Par Healthcare Ltd.	ce703715-4c11-472c-9270-daac87b7be05	2025-12-19	Warnings	Exact identifier application number: M017
Aspercreme with Lidocaine Foot Pain Creme	LIDOCAINE HYDROCHLORIDE	Chattem, Inc.	da82cc0e-cc39-408e-87e1-c35bb6f9f51e	2025-12-19	Warnings	Exact identifier application number: M017
Health Trak Plus Menthol-Infused Pain Relief Socks	MENTHOL	Railroad Sock LLC	43413e55-1db2-fc1a-e063-6394a90a7167	2025-12-18	Warnings	Exact identifier application number: M017
BIO-ICE	MENTHOL, CAMPHOR	Electrostim Medical Services Inc. d/b/a EMSI	1bfd1468-9139-43b1-9709-d47b63d17cfb	2025-12-18	Warnings	Exact identifier application number: M017
Lidotrode	LIDOCAINE	Strand Health Group	1fd20b9a-b8bc-c94f-e063-6394a90a2b69	2025-12-18	Warnings	Exact identifier application number: M017
A Health Itch Relief Gel	ITCH RELIEF GEL	Bionpharma, Inc.	ecf5decb-c98b-7739-e053-2995a90a5541	2025-12-18	Warnings	Exact identifier application number: M017
After Burn	2.5% LIDOCAINE HCL	Tender Corporation d/b/a Adventure Ready Brands	4640395f-a76c-d022-e063-6294a90adde6	2025-12-18	Warnings	Exact identifier application number: M017
SPARTAN WIPES	ENDURANCE WIPES	TIV PRIME SRL	26d02431-2c95-001c-e063-6394a90a29c7	2025-12-18	Warnings	Exact identifier application number: M017
Stopain Extra Strength Continuous	MENTHOL	Troy Manufacturing, Inc.	a0f76968-d22c-4b1c-a9e6-8d0179a2e98e	2025-12-18	Warnings	Exact identifier application number: M017
ZIMS MAX FREEZE	LIDOCAINE HYDROCHLORIDE AND MENTHOL,	KOBAYASHI Healthcare International, Inc.	e364ff83-4aaf-4897-a7da-06581bc321f2	2025-12-18	Warnings	Exact identifier application number: M017
Tiger Balm White Regular Strength	CAMPHOR (SYNTHETIC) AND MENTHOL	Haw Par Healthcare Ltd.	f406161e-a9c4-47d1-8b21-93b1b7938063	2025-12-17	Warnings	Exact identifier application number: M017
Resinol	PETROLATUM AND RESORCINOL	ResiCal, Inc.	03f57a4a-f94b-4ba6-b709-41cfb6e16261	2025-12-17	Warnings	Exact identifier application number: M017
HealthWise Maximum Pain Relief	LIDOCAINE	Veridian Healthcare	afc3c16d-0076-44b2-ae7e-5f36d4d8088e	2025-12-17	Warnings	Exact identifier application number: M017
HealthWise Max Lidocaine plus Menthol	LIDOCAINE, MENTHOL	Veridian Healthcare	f39a27da-6799-4fc6-97ca-101eac4a9360	2025-12-17	Warnings	Exact identifier application number: M017

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
TC2D6JAD40	DIPHENHYDRAMINE HYDROCHLORIDE	147-24-0	DIPHENHYDRAMINE HYDROCHLORIDE
FM5526K07A	ZINC ACETATE	5970-45-6	ZINC ACETATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1092428	Banophen Cream 2 % / 0.1 % Topical Cream	PSN	9758d886-bd58-4eb2-a827-fa8e7fee2b7c	5
1087026	diphenhydrAMINE HCl 2 % / zinc acetate 0.1 % Topical Cream	PSN	9758d886-bd58-4eb2-a827-fa8e7fee2b7c	5
1092428	diphenhydramine hydrochloride 20 MG/ML / zinc acetate 1 MG/ML Topical Cream [Banophen Cream]	SBD	9758d886-bd58-4eb2-a827-fa8e7fee2b7c	5
1087026	diphenhydramine hydrochloride 20 MG/ML / zinc acetate 1 MG/ML Topical Cream	SCD	9758d886-bd58-4eb2-a827-fa8e7fee2b7c	5
1092428	Banophen Cream (diphenhydramine hydrochloride 2 % / zinc acetate 0.1 % ) Topical Cream	SY	9758d886-bd58-4eb2-a827-fa8e7fee2b7c	5
1087026	diphenhydramine hydrochloride 2 % / zinc acetate 0.1 % Topical Cream	SY	9758d886-bd58-4eb2-a827-fa8e7fee2b7c	5
1087026	diphenhydrAMINE HCl 2 % / zinc acetate 0.1 % Topical Cream	PSN	82e6a91c-fb8b-42b5-8b01-3db180b9d7fc	1
1087026	diphenhydramine hydrochloride 20 MG/ML / zinc acetate 1 MG/ML Topical Cream	SCD	82e6a91c-fb8b-42b5-8b01-3db180b9d7fc	1
1087026	diphenhydramine hydrochloride 2 % / zinc acetate 0.1 % Topical Cream	SY	82e6a91c-fb8b-42b5-8b01-3db180b9d7fc	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0904-5354-31	00904535431	1 TUBE in 1 CARTON (0904-5354-31) / 28 g in 1 TUBE	1 tube	2009-06-19	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Major Pharmaceuticals Banophen™ Drug Facts	Major Pharmaceuticals	2026-02-13	HUMAN OTC DRUG LABEL	5
Diphenhydramine - Physicians Total Care, Inc.	Physicians Total Care, Inc.	2012-06-05	HUMAN OTC DRUG LABEL	1