Dimetane

Product NDC: 57237-367
11-digit product format: 572370367
Labeler code: 57237
Product ID: 57237-367_958e9dae-4d1c-40fc-b84d-20f2ed6996c0
Type: HUMAN OTC DRUG
Nonproprietary name: Diphenhydramine Hydrochloride
Dosage form: CAPSULE, LIQUID FILLED
Route: ORAL
Labeler: Rising Pharma Holdings, Inc.
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2026-01-27
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: Dimetane
Listing expiration: 2027-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
8GTS82S83M	Internal UNII lookup
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
1020477	Internal RxNorm lookup
1049909	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
484d6a37-b84e-4ead-bb89-9c3d8c3bcd2f	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	Strength	SPL version
57237-367-01	Dimetane	100 in 1 BOTTLE	CAPSULE, LIQUID FILLED	100		1
57237-367-99	Dimetane	1000 in 1 BOTTLE	CAPSULE, LIQUID FILLED	1000		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
57237-367-01	EA - Each	57237-367	e5cbb116-bb64-4ac1-b056-693aaf678377	1	2026-02-05
57237-367-99	EA - Each	57237-367	52918ffe-99b2-4ea2-b110-01ee01c5a25c	1	2026-02-05

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 50 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	LEADER/ Cardinal Health 110, Inc.	e33cbd1d-1848-145a-e053-2995a90aeb50	2026-02-20	Warnings	Exact identifier application number: M012
Head Congestion and Flu Severe Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Rite Aid Corporation	416080a9-e817-485b-a4ae-6c9d0152c165	2026-02-20	Warnings	Exact identifier application number: M012
Walmart Dye Free Chidrens Allergy Chews	DIPHENHYDRAMINE HCL	WALMART STORES INC	18436026-b0e4-4481-a647-d735a27d0b00	2026-02-19	Warnings	Exact identifier application number: M012
Vaporizing	CAMPHOR	Meijer, Inc.	7afc98d7-f64f-42d5-9022-28ad6b01db8a	2026-02-19	Warnings, Adverse reactions	Exact identifier application number: M012
CHILDRENS COLD AND COUGH	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE	Kroger Company	8196b482-070e-4d7d-8943-129141f926ee	2026-02-19	Warnings	Exact identifier application number: M012
Walmart Dye Free Chidrens Allergy Chews Bubblegum	DIPHENHYDRAMINE HCL	WALMART STORES INC	9f83d2f0-9718-4f2b-bc7f-e29ba2917412	2026-02-19	Warnings	Exact identifier application number: M012
tussin dm max	DEXTROMETHORPHAN HBR, GUAIFENESIN	Kroger Company	be9aaf66-6c59-4042-88e2-acd920dcf992	2026-02-19	Warnings	Exact identifier application number: M012
Allergy Relief Dye-Free	DIPHENHYDRAMINE HCL	CVS Pharmacy	08459cf4-feb3-4283-88e1-d61e030c57f9	2026-02-19	Warnings	Exact identifier application number: M012
allergy relief	CHLORPHENIRAMINE MALEATE	Rite Aid Corporation	b0d70488-ea1d-4c1d-bd07-53dfb0e4d03c	2026-02-18	Warnings	Exact identifier application number: M012
Walgreens Wild Cherry Pectin Throat Drops	PECTIN	Walgreens	424fda2d-c1e5-0ed9-e063-6394a90a06ea	2026-02-18	Warnings	Exact identifier application number: M012
cough suppressant and topical analgesic	CAMPHOR, EUCALYPTUS OIL, MENTHOL	Target Corporation	df21d9d6-36a9-49cf-a29c-c4a573899bd5	2026-02-18	Warnings, Adverse reactions	Exact identifier application number: M012
Allergy Relief	CHLORPHENIRAMINE MALEATE	Amerisource Bergen	eeda80ff-212d-428e-a0c6-782f271357b4	2026-02-18	Warnings	Exact identifier application number: M012
good sense night time	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	L. Perrigo Company	e47dffdf-5778-4804-8ce2-54c5a72bba3a	2026-02-18	Warnings	Exact identifier application number: M012
Chest Rub	CAMPHOR, EUCALYPTUS OIL, MENTHOL	United Natural Foods, Inc. dba UNFI	b139e7d6-bf4d-45b9-b7cf-d34e5352095c	2026-02-17	Warnings, Adverse reactions	Exact identifier application number: M012
Chest Rub	CAMPHOR, EUCALYPTUS OIL, MENTHOL	Strategic Sourcing Services LLC	bd54bf7a-2304-4c3f-9cd2-bafea217466e	2026-02-17	Warnings, Adverse reactions	Exact identifier application number: M012
Creomulsion For Children	DEXTROMETHORPHAN HYDROBROMIDE	Socius Care, LLC	39d0e96c-1cc3-4961-e054-00144ff88e88	2026-02-17	Warnings	Exact identifier application number: M012
Creomulsion Cough Medicine Adult Formula	DEXTROMETHORPHAN HYDROBROMIDE	Socius Care, LLC	39d07486-99b7-5c06-e054-00144ff8d46c	2026-02-17	Warnings	Exact identifier application number: M012
Cold and Flu Severe, Day, Night	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR. GUAIFENESIN, PHENYLEPHRINE HCL	L.N.K. International, Inc.	6e6bae79-1231-4b74-81c1-f0c914ed4af3	2026-02-17	Warnings	Exact identifier application number: M012
COUGH AND CHEST CONGESTION	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	dfe69c12-b5fe-46d1-a3bf-ef3729c2e786	2026-02-17	Warnings	Exact identifier application number: M012
NIGHTTIME COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	3fb49f64-2d77-44db-8186-5904837eedbe	2026-02-17	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
1049909	diphenhydrAMINE HCl 25 MG Oral Capsule	PSN	484d6a37-b84e-4ead-bb89-9c3d8c3bcd2f	1
1020477	diphenhydrAMINE HCl 50 MG Oral Capsule	PSN	484d6a37-b84e-4ead-bb89-9c3d8c3bcd2f	1
1049909	diphenhydramine hydrochloride 25 MG Oral Capsule	SCD	484d6a37-b84e-4ead-bb89-9c3d8c3bcd2f	1
1020477	diphenhydramine hydrochloride 50 MG Oral Capsule	SCD	484d6a37-b84e-4ead-bb89-9c3d8c3bcd2f	1
1020477	diphenhydramine HCl 50 MG Oral Capsule	SY	484d6a37-b84e-4ead-bb89-9c3d8c3bcd2f	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
57237-367-01	57237036701	100 CAPSULE, LIQUID FILLED in 1 BOTTLE (57237-367-01)	2026-01-27	No	No	Current
57237-367-99	57237036799	1000 CAPSULE, LIQUID FILLED in 1 BOTTLE (57237-367-99)	2026-01-27	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Dimetane™ Allergy Relief -25mg Dimetane™ Allergy Relief Extra Strength -50mg	Rising Pharma Holdings, Inc.	2026-01-19	HUMAN OTC DRUG LABEL	1