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 2 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ActivICE	MENTHOL	Medline Industries, LP	834adeb9-38ad-0cfe-e053-2991aa0af82f	2026-09-01	Warnings	Exact identifier application number: M017
La Vaquita New Extra	METHYL SALICYLATE, MENTHOL	Delon Laboratories (1990) Ltd	3097a01b-cee5-492f-b65a-63992fb28e3a	2026-09-01	Warnings	Exact identifier application number: M017
Terramed Just Think Comfort Hydrocortisone 1% Cream	HYDROCORTISONE	Rida LLC	0d2c0c2c-370f-4adb-b0ea-1e218c927f8b	2026-09-01	Warnings	Exact identifier application number: M017
Itch Stopping	DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE	HyVee Inc	53157137-b980-45d2-aa10-8c111c0ec2f4	2026-08-31	Warnings	Exact identifier application number: M017
EAYONYUMT NECK PAIN RELIEF	MENTHOL	Wuhan Ruihengjie Technology Co., Ltd.	5a450e68-07a7-a4bb-e063-6294a90a97c9	2026-08-30	Warnings	Exact identifier application number: M017
EAYONYUM BACK PAIN RELIEVING	MENTHOL	Wuhan Ruihengjie Technology Co., Ltd.	5a458280-4f9c-5af6-e063-6394a90acb2e	2026-08-30	Warnings	Exact identifier application number: M017
EAYONYUM KNEE PAIN RELIEVING	MENTHOL	Wuhan Ruihengjie Technology Co., Ltd.	5a45d19f-c753-71eb-e063-6294a90a4805	2026-08-30	Warnings	Exact identifier application number: M017
Good Neighbor Pharmacy Hydrocortisone With Aloe for Sensitive Skin	HYDROCORTISONE	AmerisourceBergen	c5c5b5ca-b4d4-4fa8-b647-b3ccb2966495	2026-08-30	Warnings	Exact identifier application number: M017
Olu Pain Management	LIDOCAINE AND CAMPHOR	HAWAII REPACK, INC.	31ed3d82-ba12-46b2-b0ec-7e5e019efc10	2026-08-28	Warnings	Exact identifier application number: M017
4% Lidocaine Patches	4% LIDOCAINE PATCHES	Shenzhen Chaoxiji Technology Co.,Ltd.	5a177987-7c05-f07f-e063-6394a90aa9ba	2026-08-28	Warnings	Exact identifier application number: M017
Relieved Pro Wrap	4% LIDOCAINE PATCH	Transfer Technology	5a1c6ebf-ad3f-c47b-e063-6294a90aa19a	2026-08-28	Warnings	Exact identifier application number: M017
Sinsinpas Arex Pain Relieving Patch, Medium	CAMPHOR, MENTHOL, METHYL SALICYLATE	Sinsin Pharmaceutical Co., Ltd.	46453ef2-512b-4852-e063-6394a90a8912	2026-08-28	Warnings	Exact identifier application number: M017
Sinsinpas arex patch large	CAMPHOR, MENTHOL, METHYL SALICYLATE	Sinsin Pharmaceutical Co., Ltd.	47c242da-56cd-bea1-e063-6394a90a41de	2026-08-28	Warnings	Exact identifier application number: M017
4% Lidocaine Patches	4% LIDOCAINE PATCHES	Shenzhen Chaoxiji Technology Co.,Ltd.	5a16c6aa-3ab0-3e46-e063-6294a90a6d8f	2026-08-27	Warnings	Exact identifier application number: M017
Lidocaine Patch 4%	LIDOCAINE 4%	Global America Group LLC	1eec782d-0e56-43d2-b842-da0ae47c5dc9	2026-08-26	Warnings	Exact identifier application number: M017
Careland Lidocaine Plus Menthol Pain Relieving	LIDOCAINE, MENTHOL	Planet (Anhui) Pharmaceutical Co., Ltd	0f928b5b-60f5-4a45-a409-c601eb330487	2026-08-26	Warnings	Exact identifier application number: M017
PARCHE CALIENTE	CAPSAICINA AND MENTOL	DW SUPPORT LLC	59f2708e-295a-ccb3-e063-6394a90ad395	2026-08-26	Warnings	Exact identifier application number: M017
CVS Pain Relief	LIDOCAINE	CVS Pharmacy	4ecbc263-e0d4-18d5-e063-6294a90a72e9	2026-08-26	Warnings	Exact identifier application number: M017
CVS Pain Relief Lidocaine XL	LIDOCAINE	CVS Pharmacy	4aa286e3-e274-8095-e063-6394a90ae871	2026-08-26	Warnings	Exact identifier application number: M017
TERAPIA DE DIA Y NOCHE	PAIN RELIEVING PATCH	DW SUPPORT LLC	59f44135-865b-9d7d-e063-6294a90a9dd9	2026-08-26	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