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 13 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dr Sabharwals	METHYL SALICYLATE 10% GEL PATCH	Dr. Sabharwal's Wound Care	4a7790bb-25cb-72b8-e063-6294a90a6b9c	2026-06-29	Warnings	Exact identifier application number: M017
Calamine Plus Pramoxine HCl	CALAMINE PLUS SPRAY	Target Corporation	36602b7a-99c0-f6a4-e063-6294a90a8758	2026-06-29	Warnings	Exact identifier application number: M017
FIRST SHIELD	BENZALKONIUM CHLORIDE, LIDOCAINE HCI	Unishield	f86f7446-b741-9f40-e053-6394a90a4422	2026-06-29	Warnings	Exact identifier application number: M017
MQ Lidocaine Pain Relief Patch	LIDOCAINE PAIN RELIEF PATCH	Zhengzhou Miaoqi Medical Technology Co., Ltd.	5560cdab-cee8-f6ec-e063-6294a90ad024	2026-06-29	Warnings	Exact identifier application number: M017
GNP Lidocaine Maximum Strength	LIDOCAINE HCL	AMERISOURCE BERGEN	9f559c20-c9ac-e480-e053-2a95a90a8fce	2026-06-29	Warnings	Exact identifier application number: M017
NUMBING	LIDOCAINE	YIYANGYUAN LIFE SCIENCES (HONG KONG) CO., LIMITED	5553385d-c1e6-1242-e063-6394a90aa5a7	2026-06-28	Warnings	Exact identifier application number: M017
MOROVAN	LIDOCAINE	HONG KONG UNORDERED TRADING CO., LIMITED	550c8d2d-e0d7-1531-e063-6394a90a374d	2026-06-25	Warnings	Exact identifier application number: M017
Marie Originals Medicated Outdoor Anti Itch	HYDROCORTISONE SPRAY	Marie's Original Formulas, LLC	5517ee5f-1c51-cfd6-e063-6294a90af56f	2026-06-25	Warnings	Exact identifier application number: M017
Marie Originals Medicated Outdoor Anti Itch	HYDROCORTISONE SPRAY	Marie's Original Formulas LLC	55188ede-68cd-fcc6-e063-6394a90a5c58	2026-06-25	Warnings	Exact identifier application number: M017
Hydrocortisone with Aloe	HYDROCORTISONE CREAM 1%	NuCare Pharmaceuticals, Inc.	54f07a23-213f-ca46-e063-6394a90a0034	2026-06-24	Warnings	Exact identifier application number: M017
Terramed Just Think Comfort HerpCare EXTERNAL ANALGESIC FOR THE TEMPORARY RELIEF OF ITCHING AND IRRITATION	MENTHOL,PRAMOXINE HYDROCHLORIDE	Rida LLC	b62d09e4-7ced-49a9-8c83-3a8ef580f25a	2026-06-23	Warnings	Exact identifier application number: M017
Terramed Just Think Comfort HerpCare Intimate Wash EXTERNAL ANALGESIC FOR THE TEMPORARY RELIEF OF ITCHING AND IRRITATION	PRAMOXINE HYDROCHLORIDE	Rida LLC	5b2cb1bd-2f1e-4670-b40e-6c058bfd12a2	2026-06-23	Warnings	Exact identifier application number: M017
Pain Relieving cleansing spary	BENZALKONIUM CHLORIDE AND LIDOCAINE HCI	Trifecta Pharmaceuticals USA, LLC.	48edbb8d-0c35-91d8-e063-6394a90a71b8	2026-06-19	Warnings	Exact identifier application number: M017
Pain Relief	MENTHOL	Trifecta Pharmaceuticals USA, LLC.	493ab515-5cda-7b5a-e063-6294a90a295b	2026-06-19	Warnings	Exact identifier application number: M017
Tiger Balm Muscle Rub	METHYL SALICYLATE, MENTHOL, UNSPECIFIED FORM, AND CAMPHOR (SYNTHETIC)	Haw Par Healthcare Ltd.	011fc383-10bc-44cf-a67c-4be45fef33e0	2026-06-19	Warnings	Exact identifier application number: M017
CVS Health Scalp Relief	SALICYLIC ACID	CVS Health	8de46015-817c-4cd9-95f8-293424f2a5c4	2026-06-19	Warnings	Exact identifier application number: M017
Careland Kinesiology Dual Action Pain Relieving Tape	LIDOCAINE	Planet (Anhui) Pharmaceutical Co., Ltd.	67e0b3c5-e88e-4c48-a1e8-39f502ac249d	2026-06-18	Warnings	Exact identifier application number: M017
Zensa	LIDOCAINE	Alera Skin Care Products Inc.	549348ec-2eb2-3781-e063-6294a90a2f4a	2026-06-18	Warnings	Exact identifier application number: M017
SprayPain Away	CAPSAICIN	Proximity Capital Partners LLC dba Asutra	c603e999-2316-496a-e053-2995a90ab4ed	2026-06-17	Warnings	Exact identifier application number: M017
SprayPain Away Lavender	CAPSAICIN	Proximity Capital Partners LLC dba Asutra	547e2167-ade0-ac7e-e063-6294a90a18ea	2026-06-17	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