Banophen

Product NDC: 0904-5551
11-digit product format: 009045551
Labeler code: 0904
Product ID: 0904-5551_4eb3f9e3-fdb3-4298-b855-c4c9165cf1d8
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: 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	25 mg/1

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

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 48 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Kids Daytime Cough and Nighttime Cough combo pack	DEXTROMETHORPHAN HBR, GUAIFENESIN, CHLORPHENIRAMINE MALEATE	Genexa Inc.	4bad39f1-86d4-b8a1-e063-6394a90a7a95	2026-02-25	Warnings	Exact identifier application number: M012
dimaphen dm	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Major Pharmaceuticals	67072a38-1ae7-4e59-bfed-71db0d93215d	2026-02-25	Warnings	Exact identifier application number: M012
leader tussin cf	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Cardinal Health 110, LLC. dba Leader	b3e3699b-b36c-453c-8f3b-0001388c8e82	2026-02-25	Warnings	Exact identifier application number: M012
Sinus Pressure, Pain and Cough	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Walgreen Company	97554f40-f9aa-4dbf-a6f2-de6197236ab4	2026-02-25	Warnings	Exact identifier application number: M012
Chest Rub	CAMPHOR, EUCALYPTUS OIL, MENTHOL	Family Dollar Stores, Inc	1b50b865-3dfc-4b3f-86d5-5e91ca772445	2026-02-24	Warnings, Adverse reactions	Exact identifier application number: M012
Vaproizing	CAMPHOR	H E B	577fda09-588a-4c2e-ada5-eeda32d1aabe	2026-02-24	Warnings, Adverse reactions	Exact identifier application number: M012
Sore Throat Logenzes Sore Throat	BENZOCAINE AND MENTHOL	Major Pharmaceuticals	11416620-4892-44ba-9780-db27efff6743	2026-02-24	Warnings	Exact identifier application number: M012
Family Wellness SF Honey Lemon Cough Drops	MENTHOL	Family Dollar	4437853d-1f42-a41d-e063-6294a90aa81e	2026-02-24	Warnings	Exact identifier application number: M012
Cold and Flu Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Best Choice (Valu Merchandisers Company)	64a93715-e7b1-4de1-8099-8ad6c585d517	2026-02-24	Warnings	Exact identifier application number: M012
Cough and Chest Congestion DM Daytime	DEXTROMETHORPHAN HBR, GUAIFENESIN	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	86af74c2-9183-4ee9-ad1e-d88dfc8bf47d	2026-02-24	Warnings	Exact identifier application number: M012
Cough DM Nighttime	DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	39adf23e-76f3-42e1-a9f4-55feb38078e5	2026-02-24	Warnings	Exact identifier application number: M012
Revasol Tussin DM Cough Suppressant Expectorant	DEXTROMETHORPHAN HBR, GUAIFENESIN	Rnv LLC	4b7fd320-2f39-fa1a-e063-6294a90ada9e	2026-02-23	Warnings	Exact identifier application number: M012
Dimetapp Cold and Allergy	BROMPHENIRAMINE MALEATE AND PHENYLEPHRINE HYDROCHLORIDE	Foundation Consumer Brands	47317865-4310-4f07-8815-f3130963307d	2026-02-23	Warnings	Exact identifier application number: M012
Dimetapp Cold and Cough and Dimetapp Nighttime Cold and Congestion	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND DIPHENHYDRAMINE HYRDOCHLORIDE	Foundation Consumer Brands	42720fa0-fcdd-4614-80b2-16d0ada345b1	2026-02-23	Warnings	Exact identifier application number: M012
Dimetapp Cold and Cough	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	Foundation Consumer Brands	cc09a8c5-d173-4261-b838-96e6a16e2ff9	2026-02-23	Warnings	Exact identifier application number: M012
Dimetapp Nighttime Cold and Congestion	DIPHENHYDRAMINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE	Foundation Consumer Brands	96a1055f-e831-4f4b-8af3-7a41838c194c	2026-02-23	Warnings	Exact identifier application number: M012
Dimetapp Cold and Cough and Nighttime Cold and Congestion	DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE, BROMPHENIRAMINE MALEATE, AND DEXTROMETHORPHAN HYDROBROMIDE	Foundation Consumer Brands	1fbe1ce0-5e3e-4af5-a5f1-85ed12ced246	2026-02-23	Warnings	Exact identifier application number: M012
Chest Rub	CAMPHOR, EUCALYPTUS OIL, MENTHOL	Better Living Brands, LLC	0948648c-1c5f-4225-a754-120ca8859f19	2026-02-23	Warnings, Adverse reactions	Exact identifier application number: M012
Revasol Tussin	GUAIFENESIN	Rnv LLC	f66dc593-9023-40e8-9cc3-0380b04b4305	2026-02-23	Warnings	Exact identifier application number: M012
Equate Vaporizing	CAMPHOR, EUCALYPTUS OIL, MENTHOL	Wal-Mart Stores Inc	3006971b-784c-43fd-91a6-d96876bbf185	2026-02-23	Warnings	Exact identifier application number: M012

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.	2026-10-19	HUMAN OTC DRUG LABEL	17
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