Banophen

Product NDC: 0904-5551
11-digit product format: 009045551
Labeler code: 0904
Product ID: 0904-5551_e0443532-ae16-498a-86f5-c706edb11aa6
Type: HUMAN OTC DRUG
Nonproprietary name: Diphenhydramine HCl
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Major Pharmaceuticals
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 1990-03-02
Substance: DIPHENHYDRAMINE HYDROCHLORIDE
Active strength: 25 mg/1
Pharmacologic classes: Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
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 194 · 3,880 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Severe Congestion and Pain	ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL	Family Dollar Services Inc	ce590997-3cae-4f22-ac39-2b14d39494bc	2026-07-30	Warnings	Exact identifier application number: M012
Robitussin Direct Cough	DEXTROMETHORPHAN HYDROBROMIDE	Haleon US Holdings LLC	70c9556b-063a-4fb3-96f6-1d4ffa495ed4	2026-07-30	Warnings	Exact identifier application number: M012
Major Nasal Decongestant	OXYMETAZOLINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	a302e341-1c00-4c3d-b71f-c4c0b307aa67	2026-07-29	Warnings	Exact identifier application number: M012
Pain Reliever PM Extra Strength	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	Walgreens	4c737cd6-fe56-4cef-887c-cd6cf83b254c	2026-07-29	Warnings	Exact identifier application number: M012
ROBITUSSIN LONG-ACTING COUGHGELS	DEXTROMETHORPHAN HYDROBROMIDE	Haleon US Holdings LLC	472c5c1f-eb5a-444b-a17e-f0d71007fb15	2026-07-29	Warnings	Exact identifier application number: M012
DAYTIME COLD AND FLU NITETIME COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Meijer Distribution Inc	3a33c6ce-aada-4099-8c61-49c86c0fc1a8	2026-07-29	Warnings	Exact identifier application number: M012
Tussin DM Max Nighttime	DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Wal-Mart Stores Inc	668c92ce-6c1f-4ab3-b0dd-822b0768cb5e	2026-07-29	Warnings	Exact identifier application number: M012
Benadryl	DIPHENHYDRAMINE HYDROCHLORIDE	Kenvue Brands LLC	702f9786-7ce9-43e4-921d-e1db09612127	2026-07-28	Warnings	Exact identifier application number: M012
LoHist-D	CHLORPHENIRAMINE MALEATE / PSEUDOEPHEDRINE HCL	Larken Laboratories, Inc.	efaa354e-c25c-405b-9d30-001c2796978c	2026-07-28	Warnings	Exact identifier application number: M012
NIGHTTIME SEVERE COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	d1115a55-35cd-4f20-8872-f42983a5ebcd	2026-07-28	Warnings	Exact identifier application number: M012
TUSSIN	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Safeway	a5e2bda4-2da6-4c20-855d-2888dadf0c3a	2026-07-28	Warnings	Exact identifier application number: M012
DM Maximum	DEXTROMETHORPHAN HBR, GUAIFENESIN	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	f6029b04-e681-40fc-be4f-14091b76dd4e	2026-07-27	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	CVS PHARMACY	e958eef1-8aae-4365-ac64-95a9e8e7e0f2	2026-07-27	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	DOLGENCORP INC	38400854-27fa-e291-e063-6294a90a5c4e	2026-07-27	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	Better Living Brands, LLC	65802aa7-64e7-4435-ad6b-65895fba17ce	2026-07-27	Warnings	Exact identifier application number: M012
Cold and Flu Severe	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, TRIPROLIDINE HCL	Walgreen Company	0a48f650-ad2a-4105-9ff4-2bc4d94b46d3	2026-07-27	Warnings	Exact identifier application number: M012
Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Walgreen Company	84202ebe-97b6-4be2-bb09-7f2729303f96	2026-07-27	Warnings	Exact identifier application number: M012
Daytime Severe Cold and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Rite Aid Corporation	8d41defe-8120-4cbb-b42e-c805cc5a794b	2026-07-24	Warnings	Exact identifier application number: M012
Childrens Benadryl ALLERGY	DIPHENHYDRAMINE HYDROCHLORIDE	Kenvue Brands LLC	fc9181b9-c92d-493e-8d7c-4a4239c6c092	2026-07-24	Warnings	Exact identifier application number: M012
Acetaminophen, Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDE	Prodose, Inc.	3afc88c7-388a-dbd9-e063-6294a90a4faf	2026-07-24	Warnings	Exact identifier application number: M012

Additional Listing Data#

Finished product: Yes
Brand name base: Banophen
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DIPHENHYDRAMINE HYDROCHLORIDE	25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1049630	Internal RxNorm lookup
1092421	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
69b7f7ca-7a3a-4fe6-a9bb-90b0e6ad62c1	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
0e2e0f88-b076-afe1-4bdd-32bca4375bec	Product name	3	20250127
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	SPL version
0904-5551-24	Banophen	12 in 1 BLISTER PACK	TABLET, FILM COATED	12	16
0904-5551-24	Banophen	2 in 1 CARTON	TABLET, FILM COATED	2	16
0904-5551-59	Banophen	1 in 1 CARTON	TABLET, FILM COATED	1	16
0904-5551-59	Banophen	100 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	100	16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0904-5551-24	EA - Each	0904-5551	805dcd85-34b6-4a0a-9406-d46680925db8	1	2012-07-24
0904-5551-59	EA - Each	0904-5551	6037c229-d392-48f1-bbd8-febe968f67a3	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DIPHENHYDRAMINE HYDROCHLORIDE	ACTIVE INGREDIENT	TC2D6JAD40	BANOPHEN (DIPHENHYDRAMINE HCL) TABLET [MAJOR PHARMACEUTICALS]	4
DIPHENHYDRAMINE	ACTIVE MOIETY	8GTS82S83M	BANOPHEN (DIPHENHYDRAMINE HCL) TABLET [MAJOR PHARMACEUTICALS]	4
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	INACTIVE INGREDIENT	L11K75P92J	BANOPHEN (DIPHENHYDRAMINE HCL) TABLET [MAJOR PHARMACEUTICALS]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	BANOPHEN (DIPHENHYDRAMINE HCL) TABLET [MAJOR PHARMACEUTICALS]	4
D&C RED NO. 27	INACTIVE INGREDIENT	2LRS185U6K	BANOPHEN (DIPHENHYDRAMINE HCL) TABLET [MAJOR PHARMACEUTICALS]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	BANOPHEN (DIPHENHYDRAMINE HCL) TABLET [MAJOR PHARMACEUTICALS]	4
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	BANOPHEN (DIPHENHYDRAMINE HCL) TABLET [MAJOR PHARMACEUTICALS]	4
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	BANOPHEN (DIPHENHYDRAMINE HCL) TABLET [MAJOR PHARMACEUTICALS]	4
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	BANOPHEN (DIPHENHYDRAMINE HCL) TABLET [MAJOR PHARMACEUTICALS]	4
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	BANOPHEN (DIPHENHYDRAMINE HCL) TABLET [MAJOR PHARMACEUTICALS]	4
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	BANOPHEN (DIPHENHYDRAMINE HCL) TABLET [MAJOR PHARMACEUTICALS]	4
DIPHENHYDRAMINE HYDROCHLORIDE	ACTIVE INGREDIENT	TC2D6JAD40	BANOPHEN (DIPHENHYDRAMINE HCL) TABLET [CARILION MATERIALS MANAGEMENT]	2
DIPHENHYDRAMINE	ACTIVE MOIETY	8GTS82S83M	BANOPHEN (DIPHENHYDRAMINE HCL) TABLET [CARILION MATERIALS MANAGEMENT]	2
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	INACTIVE INGREDIENT	L11K75P92J	BANOPHEN (DIPHENHYDRAMINE HCL) TABLET [CARILION MATERIALS MANAGEMENT]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	BANOPHEN (DIPHENHYDRAMINE HCL) TABLET [CARILION MATERIALS MANAGEMENT]	2
D&C RED NO. 27	INACTIVE INGREDIENT	2LRS185U6K	BANOPHEN (DIPHENHYDRAMINE HCL) TABLET [CARILION MATERIALS MANAGEMENT]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	BANOPHEN (DIPHENHYDRAMINE HCL) TABLET [CARILION MATERIALS MANAGEMENT]	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	BANOPHEN (DIPHENHYDRAMINE HCL) TABLET [CARILION MATERIALS MANAGEMENT]	2
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	BANOPHEN (DIPHENHYDRAMINE HCL) TABLET [CARILION MATERIALS MANAGEMENT]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	BANOPHEN (DIPHENHYDRAMINE HCL) TABLET [CARILION MATERIALS MANAGEMENT]	2
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	BANOPHEN (DIPHENHYDRAMINE HCL) TABLET [CARILION MATERIALS MANAGEMENT]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	BANOPHEN (DIPHENHYDRAMINE HCL) TABLET [CARILION MATERIALS MANAGEMENT]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0904-5551	BANOPHEN (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [MAJOR PHARMACEUTICALS]	15	Current NDC, Legacy NDC, 4 package rows	20241103_69b7f7ca-7a3a-4fe6-a9bb-90b0e6ad62c1.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
TC2D6JAD40	DIPHENHYDRAMINE HYDROCHLORIDE	147-24-0	DIPHENHYDRAMINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1092421	BANOPHEN 25 MG Oral Tablet	PSN	69b7f7ca-7a3a-4fe6-a9bb-90b0e6ad62c1	16
1049630	diphenhydrAMINE HCl 25 MG Oral Tablet	PSN	69b7f7ca-7a3a-4fe6-a9bb-90b0e6ad62c1	16
1092421	diphenhydramine hydrochloride 25 MG Oral Tablet [Banophen]	SBD	69b7f7ca-7a3a-4fe6-a9bb-90b0e6ad62c1	16
1049630	diphenhydramine hydrochloride 25 MG Oral Tablet	SCD	69b7f7ca-7a3a-4fe6-a9bb-90b0e6ad62c1	16
1092421	Banophen 25 MG Oral Tablet	SY	69b7f7ca-7a3a-4fe6-a9bb-90b0e6ad62c1	16
1092421	BANOPHEN 25 MG Oral Tablet	PSN	e1b05e0c-3c61-4e2e-8e6c-ca1ed5bb93cd	5
1049630	diphenhydrAMINE HCl 25 MG Oral Tablet	PSN	e1b05e0c-3c61-4e2e-8e6c-ca1ed5bb93cd	5
1092421	diphenhydramine hydrochloride 25 MG Oral Tablet [Banophen]	SBD	e1b05e0c-3c61-4e2e-8e6c-ca1ed5bb93cd	5
1049630	diphenhydramine hydrochloride 25 MG Oral Tablet	SCD	e1b05e0c-3c61-4e2e-8e6c-ca1ed5bb93cd	5
1092421	Banophen 25 MG Oral Tablet	SY	e1b05e0c-3c61-4e2e-8e6c-ca1ed5bb93cd	5
1092421	BANOPHEN 25 MG Oral Tablet	PSN	62934d0f-b23d-4c03-9d60-a7bad41f9b42	3
1092421	BANOPHEN 25 MG Oral Tablet	PSN	cb498f07-75fe-47d5-9620-f87405d168af	3
1049630	diphenhydrAMINE HCl 25 MG Oral Tablet	PSN	62934d0f-b23d-4c03-9d60-a7bad41f9b42	3
1049630	diphenhydrAMINE HCl 25 MG Oral Tablet	PSN	cb498f07-75fe-47d5-9620-f87405d168af	3
1092421	diphenhydramine hydrochloride 25 MG Oral Tablet [Banophen]	SBD	62934d0f-b23d-4c03-9d60-a7bad41f9b42	3
1092421	diphenhydramine hydrochloride 25 MG Oral Tablet [Banophen]	SBD	cb498f07-75fe-47d5-9620-f87405d168af	3
1049630	diphenhydramine hydrochloride 25 MG Oral Tablet	SCD	62934d0f-b23d-4c03-9d60-a7bad41f9b42	3
1049630	diphenhydramine hydrochloride 25 MG Oral Tablet	SCD	cb498f07-75fe-47d5-9620-f87405d168af	3
1092421	Banophen 25 MG Oral Tablet	SY	62934d0f-b23d-4c03-9d60-a7bad41f9b42	3
1092421	Banophen 25 MG Oral Tablet	SY	cb498f07-75fe-47d5-9620-f87405d168af	3
1092421	BANOPHEN 25 MG Oral Tablet	PSN	2cdbe7df-4c67-9b05-e063-6394a90a4699	1
1049630	diphenhydrAMINE HCl 25 MG Oral Tablet	PSN	2cdbe7df-4c67-9b05-e063-6394a90a4699	1
1092421	diphenhydramine hydrochloride 25 MG Oral Tablet [Banophen]	SBD	2cdbe7df-4c67-9b05-e063-6394a90a4699	1
1049630	diphenhydramine hydrochloride 25 MG Oral Tablet	SCD	2cdbe7df-4c67-9b05-e063-6394a90a4699	1
1092421	Banophen 25 MG Oral Tablet	SY	2cdbe7df-4c67-9b05-e063-6394a90a4699	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0904-5551-24	00904555124	2 BLISTER PACK in 1 CARTON (0904-5551-24) / 12 TABLET, FILM COATED in 1 BLISTER PACK	2 blister pack	1990-03-02	0000-00-00	No	No	Current
0904-5551-59	00904555159	1 BOTTLE, PLASTIC in 1 CARTON (0904-5551-59) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC		1990-03-02	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Rite Aid 44-329	Major Pharmaceuticals \| LNK International, Inc.	2025-10-27	HUMAN OTC DRUG LABEL	16
Diphenhydramine 25mg (Emergency Kits)	Health Department, Oklahoma State	2025-01-29	HUMAN PRESCRIPTION DRUG LABEL	1
Rite Aid 44-329	A-S Medication Solutions	2024-01-08	HUMAN OTC DRUG LABEL	5
Rite Aid 44-329	Proficient Rx LP	2023-12-01	HUMAN OTC DRUG LABEL	3
Rite Aid 44-329	REMEDYREPACK INC.	2022-06-09	HUMAN OTC DRUG LABEL	11
Rite Aid 44-329	Carilion Materials Management	2016-08-04	HUMAN OTC DRUG LABEL	3