Banophen

Product NDC: 0904-2035
Requested package NDC: 0904-2035-24
11-digit product format: 009042035
Labeler code: 0904
Product ID: 0904-2035_a2a395d4-45f9-9db7-e053-2995a90a6412
Type: HUMAN OTC DRUG
Nonproprietary name: Diphenhydramine HCl
Dosage form: CAPSULE
Route: ORAL
Labeler: Major Pharmaceuticals
Application: part341
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2009-01-02
Marketing end: 0000-00-00
Substance: DIPHENHYDRAMINE HYDROCHLORIDE
Active strength: 25 mg/1
NDC exclude flag: No
Listing certified through: 2021-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0904-2035	0904-2035-24	D	Discontinued by firm		2026-08-10

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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	Strength	SPL version
0904-2035-24	Banophen	2 in 1 CARTON	CAPSULE	2		17
0904-2035-24	Banophen	12 in 1 BLISTER PACK	CAPSULE	12		17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0904-2035-24	EA - Each	0904-2035	0de835bc-a9d8-4642-84e7-35ab90d9c441	1	2020-08-06
0904-2035-59	EA - Each	0904-2035	f29111b7-30ff-4ae3-bc97-b776cde00d6a	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DIPHENHYDRAMINE HYDROCHLORIDE	ACTIVE INGREDIENT	TC2D6JAD40	DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS]	9
DIPHENHYDRAMINE	ACTIVE MOIETY	8GTS82S83M	DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS]	9
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS]	9
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS]	9
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS]	9
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS]	9
GELATIN	INACTIVE INGREDIENT	2G86QN327L	DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS]	9
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS]	9
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS]	9
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS]	9
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS]	9
DIPHENHYDRAMINE HYDROCHLORIDE	ACTIVE INGREDIENT	TC2D6JAD40	BANOPHEN (DIPHENHYDRAMINE HCL) CAPSULE [MAJOR PHARMACEUTICALS]	3
DIPHENHYDRAMINE	ACTIVE MOIETY	8GTS82S83M	BANOPHEN (DIPHENHYDRAMINE HCL) CAPSULE [MAJOR PHARMACEUTICALS]	3
BUTYLPARABEN	INACTIVE INGREDIENT	3QPI1U3FV8	BANOPHEN (DIPHENHYDRAMINE HCL) CAPSULE [MAJOR PHARMACEUTICALS]	3
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	BANOPHEN (DIPHENHYDRAMINE HCL) CAPSULE [MAJOR PHARMACEUTICALS]	3
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	BANOPHEN (DIPHENHYDRAMINE HCL) CAPSULE [MAJOR PHARMACEUTICALS]	3
GELATIN	INACTIVE INGREDIENT	2G86QN327L	BANOPHEN (DIPHENHYDRAMINE HCL) CAPSULE [MAJOR PHARMACEUTICALS]	3
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	BANOPHEN (DIPHENHYDRAMINE HCL) CAPSULE [MAJOR PHARMACEUTICALS]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	BANOPHEN (DIPHENHYDRAMINE HCL) CAPSULE [MAJOR PHARMACEUTICALS]	3
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	BANOPHEN (DIPHENHYDRAMINE HCL) CAPSULE [MAJOR PHARMACEUTICALS]	3
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	BANOPHEN (DIPHENHYDRAMINE HCL) CAPSULE [MAJOR PHARMACEUTICALS]	3
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	BANOPHEN (DIPHENHYDRAMINE HCL) CAPSULE [MAJOR PHARMACEUTICALS]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0904-2035	DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE BANOPHEN (DIPHENHYDRAMINE HCL) CAPSULE [MAJOR PHARMACEUTICALS]	15	Legacy NDC, 2 package rows	20250101_04e70311-6412-4a20-84e3-f6e26d5f19ab.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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	Major Pharmaceuticals	04e70311-6412-4a20-84e3-f6e26d5f19ab	2026-02-20	Warnings	Exact identifier ndc (package): 0904-2035-24 ndc (product): 0904-2035 ndc11 (package): 00904203524

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
1092422	BANOPHEN 25 MG Oral Capsule	PSN	04e70311-6412-4a20-84e3-f6e26d5f19ab	17
1049909	diphenhydrAMINE HCl 25 MG Oral Capsule	PSN	04e70311-6412-4a20-84e3-f6e26d5f19ab	17
1020477	diphenhydrAMINE HCl 50 MG Oral Capsule	PSN	04e70311-6412-4a20-84e3-f6e26d5f19ab	17
1092422	diphenhydramine hydrochloride 25 MG Oral Capsule [Banophen]	SBD	04e70311-6412-4a20-84e3-f6e26d5f19ab	17
1049909	diphenhydramine hydrochloride 25 MG Oral Capsule	SCD	04e70311-6412-4a20-84e3-f6e26d5f19ab	17
1020477	diphenhydramine hydrochloride 50 MG Oral Capsule	SCD	04e70311-6412-4a20-84e3-f6e26d5f19ab	17
1092422	Banophen 25 MG Oral Capsule	SY	04e70311-6412-4a20-84e3-f6e26d5f19ab	17
1020477	diphenhydramine HCl 50 MG Oral Capsule	SY	04e70311-6412-4a20-84e3-f6e26d5f19ab	17
1049909	diphenhydrAMINE HCl 25 MG Oral Capsule	PSN	6f1caac9-abc4-4f37-8c42-8d3fc6360ba9	1
1049909	diphenhydrAMINE HCl 25 MG Oral Capsule	PSN	9d956f5d-a0f5-49c9-be01-28a4ae7857aa	1
1049909	diphenhydrAMINE HCl 25 MG Oral Capsule	PSN	c10c0c55-b214-4e73-a3c5-ba1a30e4955f	1
1049909	diphenhydramine hydrochloride 25 MG Oral Capsule	SCD	6f1caac9-abc4-4f37-8c42-8d3fc6360ba9	1
1049909	diphenhydramine hydrochloride 25 MG Oral Capsule	SCD	9d956f5d-a0f5-49c9-be01-28a4ae7857aa	1
1049909	diphenhydramine hydrochloride 25 MG Oral Capsule	SCD	c10c0c55-b214-4e73-a3c5-ba1a30e4955f	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0904-2035-24	00904203524	2 BLISTER PACK in 1 CARTON (0904-2035-24) > 12 CAPSULE in 1 BLISTER PACK	2 blister pack	2009-01-02	2021-08-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
0835&0836(box unit)-Major	Major Pharmaceuticals	2026-02-20	HUMAN OTC DRUG LABEL	17
Calmatrol ®	Goldman Pharmaceutical Group Inc \| Goldman Pharmaceutical Group, Inc.	2019-02-20	OTC ANIMAL DRUG LABEL	1
Calmatrol ®	Goldman Pharmaceutical Group Inc \| Goldman Pharmaceutical Group, Inc.	2019-02-19	OTC ANIMAL DRUG LABEL	1
Major 44-190-Delisted	Major Pharmaceuticals \| LNK International, Inc.	2017-11-16	HUMAN OTC DRUG LABEL	8
Diphenhydramine hydrochloride	Central Texas Community Health Centers	2016-03-22	HUMAN OTC DRUG LABEL	1