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

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 153 · 3,056 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Icy Hot Original Nighttime Recovery Pain Relief No Mess Roll On	MENTHOL	Chattem, Inc.	aa40c907-eeb5-4fda-b35e-439cbecc178c	2026-07-31	Warnings	Exact identifier application number: M017
Aspercreme with Lidocaine Dry	LIDOCAINE	Chattem, Inc.	008abaaa-5e12-4246-a7f5-66f3966acf28	2026-07-30	Warnings	Exact identifier application number: M017
Icy Hot Performance No-Mess Pain Relief Cream	MENTHOL 16%, CAMPHOR 11%	Chattem, Inc.	5e3e272a-c001-4f57-9535-521ccc85ae65	2026-07-30	Warnings	Exact identifier application number: M017
Auixudin Lidocaine Pain Relief Gel-Patch	LIDOCAINE PAIN RELIEF GEL-PATCH	Henan Enokon Medical Instrument Co., Ltd.	57bc7b9e-e2f7-724b-e063-6394a90ab36f	2026-07-29	Warnings	Exact identifier application number: M017
Jinfahe Lidocaine Pain Relief Patch	LIDOCAINE PAIN RELIEF PATCH	Henan Enokon Medical Instrument Co., Ltd.	57bcd9c5-767e-b634-e063-6394a90a2878	2026-07-29	Warnings	Exact identifier application number: M017
Maximun Strength Lidocaine Patch Plus Menthol	LIDOCAINE, MENTHOL	Meijer Distribution Inc	d0468514-58ea-4d8f-b634-a65bf95c0316	2026-07-29	Warnings	Exact identifier application number: M017
Oudetas Lidocaine Cream	LIDOCAINE CREAM	Guangzhou Jingliang Cosmetics Co., Ltd.	57ca9220-2778-790a-e063-6294a90af506	2026-07-29	Warnings	Exact identifier application number: M017
Aspercreme Lidocaine No-Mess plus Lavender	LIDOCAINE HCL	Chattem, Inc.	3948a3d2-ce04-4703-8709-211e75c9c38d	2026-07-29	Warnings	Exact identifier application number: M017
LidoPro	LIDOCAINE AND MENTHOL	Clinic Pharma	cdfd6b39-b430-4e95-a0f7-682cf3d78b52	2026-07-28	Warnings	Exact identifier application number: M017
LidoPro Patch (Lidocaine 4%, Menthol 1%)	LIDOCAINE AND MENTHOL PATCH	Clinic Pharma	2b4d2105-b7ad-2695-e063-6394a90a999b	2026-07-28	Warnings	Exact identifier application number: M017
Earths Care Pain Relieving	CAMPHOR, MENTHOL, METHYL SALICYLATE	DLC Laboratories, Inc.	5c3976da-a6cb-4b94-ae41-3e86b1ab13cb	2026-07-28	Warnings	Exact identifier application number: M017
Muscle Rub Cream	MENTHOL 10%, METHYL SALICYLATE 15%	Preferred Pharmaceuticals Inc.	9e7568b6-52ae-4f7a-9bfd-503fd80a297e	2026-07-28	Warnings	Exact identifier application number: M017
Aspercreme Lidocaine with Rosemary and Mint	LIDOCAINE HYDROCHLORIDE	Chattem, Inc.	9d40bfea-85d0-4943-83e9-0c16e79a011c	2026-07-28	Warnings	Exact identifier application number: M017
KENS PAIN AND ARTHRITIS FORMULA	MENTHOL	Eezaway Relief Inc	35834473-3ad5-41ec-a110-e742aa7e2ee4	2026-07-28	Warnings	Exact identifier application number: M017
DERMFREE Lidocaine 4% NUMBING Topical Anorectal Cream	LIDOCAINE 4% NUMBING TOPICAL ANORECTAL CREAM	Wenzhou Yuyuan Pharmaceutical Co., Ltd.	57935b64-6e2e-85d0-e063-6394a90a7428	2026-07-27	Warnings	Exact identifier application number: M017
1% Hydrocortisone Anti-itch	1% HYDROCORTISONE ANTI-ITCH	ALAINA HEALTHCARE PRIVATE LIMITED	b8416467-55f7-4e5f-a5cb-3abd3e2bb577	2026-07-27	Warnings	Exact identifier application number: M017
OWELL NATURALS ARTHRITIS MAXIMUM STRENGTH	MENTHOL	OWELL NATURAL 8 LLC	57984bc2-bf1d-c423-e063-6394a90a06ae	2026-07-27	Warnings	Exact identifier application number: M017
Original Pain Relief	TOPICAL ANALGESIC LOTION	Real Time Pain Relief Inc	579bd303-9a50-4d66-e063-6294a90a6141	2026-07-27	Warnings	Exact identifier application number: M017
Lidfix Pain Relief Patch Lidocaine	LIDOCAINE	HETERO HEALTHCARE LIMITED	2149f0e3-1983-4f02-929e-ecd20357f4bb	2026-07-27	Warnings	Exact identifier application number: M017
RectoProtect	LIDOCAINE	Akron Pharma Inc.	1ca7d6cf-85a1-41a6-a07f-cff06a7edfbb	2026-07-27	Warnings	Exact identifier application number: M017

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

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