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
TC2D6JAD40	Internal UNII lookup
8GTS82S83M	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 64 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dologesic DF	ACETAMINOPHEN, DEXBROMPHENIRAMINE MALEATE	Llorens Pharmaceutical International Division	55768b45-fd98-4779-85b6-6a50c628677e	2025-12-31	Warnings	Exact identifier application number: M012
Triponel	DEXTROMETHORPHAN HBR, PSEUFOEPHEDRINE HCL, TRIPROLIDINE HCL	Llorens Pharmaceutical International Division, Inc.	e9a8deb4-0595-4f0f-ac15-f936f15aca88	2025-12-31	Warnings	Exact identifier application number: M012
Tusnel	DEXTROMETHORPHAN, GUIAFENESIN, PSEUDOEPHEDRINE HCL	Llorens Pharmaceutical International Division	805dc611-355a-4af5-bf19-464c3290c5c6	2025-12-31	Warnings	Exact identifier application number: M012
Tusnel Pediatric	DEXTROMETHORPHAN, GUIAFENESIN, PSEUDOEPHEDRINE HCL	Llorens Pharmaceutical International Division	82f447f6-4f1b-4f56-9d7d-ea02adeea88c	2025-12-31	Warnings	Exact identifier application number: M012
Triponel	DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, TRIPROLIDINE HCL	LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION	cc774d33-96ce-4992-ad30-3cb03b0d119d	2025-12-31	Warnings	Exact identifier application number: M012
Tusnel SF	DEXTROMETHORPHAN HBR, GUAIFENESIN	Llorens Pharmaceutical International Division, Inc.	cb43b4df-5ccc-416e-abcd-98f079b3f2bb	2025-12-31	Warnings	Exact identifier application number: M012
Tusnel Cough Suppressant Expectorant	DEXTROMETHORPHAN HBR, GUAIFENESIN	Llorens Pharmaceutical International Division, Inc.	af71cdbc-33d6-4303-b494-d7321721d3be	2025-12-31	Warnings	Exact identifier application number: M012
Tusnel Pediatric DM	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Llorens Pharmaceutical International Division, Inc.	63541753-de8d-42fe-a9b3-a5eac3fcdca4	2025-12-31	Warnings	Exact identifier application number: M012
Tusnel Pediatric Drops	GUAIFENESIN, PHENYLEPHRINE HCL	LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION	dbf7c43a-7b29-4c70-9e6d-8a7ea924a9d7	2025-12-31	Warnings	Exact identifier application number: M012
Tusnel DM Pediatric	DEXTROMETHORPHAN, GUIAFENESIN, PSEUDOEPHEDRINE HCL	Llorens Pharmaceutical International Division	d915eab8-013e-4ce3-b358-0d531e5ca1ba	2025-12-31	Warnings	Exact identifier application number: M012
Tusnel-DM Pediatric	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION	64e36b02-b5be-4d20-8818-cb5b23596671	2025-12-31	Warnings	Exact identifier application number: M012
Honey Lemon Cough Drops	MENTHOL	Bestco Inc.	77f89a64-f4a4-f909-e053-2a91aa0ad44d	2025-12-31	Warnings	Exact identifier application number: M012
Honey Lemon Cough Drops	MENTHOL	Bestco Inc.	77f65f59-7ea1-adce-e053-2991aa0a6f1f	2025-12-31	Warnings	Exact identifier application number: M012
Sugar Free Honey Lemon Cough Drops	MENTHOL	Bestco Inc.	77f9e176-d87a-beed-e053-2991aa0aac20	2025-12-31	Warnings	Exact identifier application number: M012
Sugar Free Cherry Cough Drops	MENTHOL	Bestco Inc.	7858f380-bef7-3d30-e053-2a91aa0a7ea6	2025-12-31	Warnings	Exact identifier application number: M012
Strawberry Cough Drops	MENTHOL	BestCo Inc.	26a22cfd-395b-4ffb-e054-00144ff88e88	2025-12-31	Warnings	Exact identifier application number: M012
Limpia Pecho	DEXTROMETHORPHAN HBR, GUAIFENESIN	Llorens Pharmaceutical International Division, Inc.	cbaea3e4-4c4b-4ff9-ae6f-95b6a2d3faf3	2025-12-31	Warnings	Exact identifier application number: M012
Cherry Sore Throat Lozenges	BENZOCAINE	Bestco Inc.	737efd41-2d59-6013-e053-2a91aa0a6c63	2025-12-31	Warnings	Exact identifier application number: M012
Best Health Menthol Cough Drops	MENTHOL	Bestco LLC	dda66a3c-9006-ff1a-e053-2a95a90abfb3	2025-12-31	Warnings	Exact identifier application number: M012
Rynex DM	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Edwards Pharmaceuticals, Inc	7be2c282-24ba-4f19-9b14-872d3f5746a7	2025-12-31	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