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 90 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Severe Cold and Flu Relief Daytime/Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCL	ARMY AND AIR FORCE EXCHANGE SERVICE	1c0c562a-68dc-4e9a-b8f3-ae70b9a4948e	2025-11-07	Warnings	Exact identifier application number: M012
Vicks DayQuil HIGH BLOOD PRESSURE COLD and FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HBR	The Procter & Gamble Manufacturing Company	ff0bffee-9a36-8246-e053-6294a90a86c7	2025-11-06	Warnings	Exact identifier application number: M012
Xlear Nasal Decongestant	NASAL SPRAY	Xlear Inc.	1c1db71a-47d0-42ac-8cbe-95e76dca185f	2025-11-06	Warnings	Exact identifier application number: M012
Robitussin Honey Cough DM Day Night Value Pack	DEXTROMETHORPHAN HBR, GUAIFENESIN, DOXYLAMINE SUCCINATE	Haleon US Holdings LLC	1bbd0157-06e6-4a3b-bac9-91ac879ba089	2025-11-06	Warnings	Exact identifier application number: M012
ValuMeds Nasal Decongestant Phenylephrine HCl	PHENYLEPHRINE HYDROCHLORIDE	Cabinet Health P.B.C.	21676b0c-6be2-464c-ae91-92e5f0d0087d	2025-11-06	Warnings	Exact identifier application number: M012
COLD AND FLU SEVERE Daytime, Nighttime	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Meijer Distribution, Inc.	04715af5-e861-496c-834a-233eb7312556	2025-11-06	Warnings	Exact identifier application number: M012
Severe Allergy Plus Sinus Headache	ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL	Wal-Mart Stores Inc	1a1f41c4-5430-4cff-873e-6547dadc8779	2025-11-06	Warnings	Exact identifier application number: M012
Target Overnight Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCL	TARGET CORPORATION	05e944d5-3473-4d8c-8df4-2ffc7474e9fa	2025-11-05	Warnings	Exact identifier application number: M012
Target Cough plus Chest Congestion DM Max with Honey	DEXTROMETHORPHAN HBR, GUAIFENESIN	TARGET CORPORATION	e36f179e-5aed-4fee-8b0a-767bf3590752	2025-11-05	Warnings	Exact identifier application number: M012
Target Maximum Strength Cold Flu and Sore Throat	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	TARGET CORPORATION	1d3ad31f-ef4d-45ba-a6e3-13d66b51d1d2	2025-11-05	Warnings	Exact identifier application number: M012
Up and Up maximum Strength fast mucus relief Severe Congestion and Cough	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Target Corporation	f007beaa-b108-46d5-8a98-853f011a8e2e	2025-11-05	Warnings	Exact identifier application number: M012
Target Childrens Cough Relief	DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN	TARGET CORPORATION	975e157a-8f8d-41ad-b55b-9f9100188ccd	2025-11-05	Warnings	Exact identifier application number: M012
Target Maximum Strength Cold Flu and Sore Throat Overnight Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL AND TRIPROLIDINE HCL	TARGET CORPORATION	6e94fdab-27ea-4c0f-a91c-735ce697304b	2025-11-05	Warnings	Exact identifier application number: M012
Target Dye Free Childrens Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	Target Corporation	76299495-7259-4bbe-8393-7eabfe22715a	2025-11-05	Warnings	Exact identifier application number: M012
TARGET CHILDRENS DT AND NT COLD and COUGH	BROMPHENIRAMINE MALEATE,DEXTROMETHORPHAN HBR,PHENYLEPHRINE HCL,DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL	TARGET CORPORATION	05ac2a40-5eee-4013-b55b-6e370a28b21c	2025-11-05	Warnings	Exact identifier application number: M012
TARGET CHILDRENs COLD and COUGH	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	TARGET CORPORATION	eb912834-1b14-484d-90f7-a8deb52c0d4e	2025-11-05	Warnings	Exact identifier application number: M012
UP and UP Daytime Childrens Multi Symptom Cold	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Target Corporation	a2d99bc8-7295-4922-acff-0cb02c91273c	2025-11-05	Warnings	Exact identifier application number: M012
Good Neighbor Pharmacy Medicated Chest Rub	CAMPHOR, MENTHOL, EUCALYPTUS OIL	AMERISOURCE BERGEN	c1843f1a-ae5b-0fdf-e053-2995a90aae38	2025-11-05	Warnings	Exact identifier application number: M012
Daytime Cold and Flu	ACETAMINOPHEN DEXTROMETHORPHAN HBR PHENYLEPHRINE HCL	QUALITY CHOICE (Chain Drug Marketing Association)	4754363d-e163-42e0-a65d-1c4bac24f6c9	2025-11-05	Warnings	Exact identifier application number: M012
Day Time Cold and Flu	ACETAMINOPHEN DEXTROMETHORPHAN HBR PHENYLEPHRINE HCL	Safeway, Inc.	76d62892-615d-4744-95aa-3be1207a0e57	2025-11-05	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