Dimetapp

Product NDC: 69536-345
11-digit product format: 695360345
Labeler code: 69536
Product ID: 69536-345_179134da-6ed7-15b1-e063-6394a90a940f
Type: HUMAN OTC DRUG
Nonproprietary name: DIPHENHYDRAMINE HYDROCHLORIDE
Dosage form: SOLUTION
Route: ORAL
Labeler: Foundation Consumer Healthcare
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2024-06-01
Substance: DIPHENHYDRAMINE HYDROCHLORIDE
Active strength: 12.5 mg/10mL
Pharmacologic classes: Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
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: Dimetapp
Brand name suffix: Nighttime Cold and Cough
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DIPHENHYDRAMINE HYDROCHLORIDE	12.5 mg/10mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
TC2D6JAD40	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1049884	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
179115ad-d610-99b2-e063-6294a90ae711	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
bf324df6-7127-7deb-def5-2681c136cd03	Product name	3	20250325
0e2e0f88-b076-afe1-4bdd-32bca4375bec	Product name	3	20250127
43a1ed49-eae2-4840-8075-cb4b33478540	Product name	1	20230425
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
ba088a92-ab5e-b2d4-e908-f5ea691b7587	Product name	7	20210201
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
3e48c9c4-918d-5d23-2f0b-d2398b06be54	Product name	1	20140508
6084a4f4-5437-c9a5-caec-5361ee075a59	Product name	1	20140508
76633df9-0d59-4b88-03ed-21dee1b966f8	Product name	1	20140508
865c72dd-0d94-daac-f728-ddd4ded2a79e	Product name	1	20140508
90c5639a-61b0-88d6-ddcf-21888e94869a	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69536-345-04	Dimetapp Cold and Cough and Dimetapp Nighttime Cold and Cough	1 in 1 CARTON	SOLUTION		12.5 mg in 10mL	1
69536-345-04	DimetappCold and Cough and Nighttime Cold and Cough	1 in 1 CARTON	SOLUTION		12.5 mg in 10mL	1
69536-345-04	DimetappNighttime Cold and Cough	1 in 1 CARTON	SOLUTION	1		1
69536-345-04	Dimetapp Cold and Cough and Dimetapp Nighttime Cold and Cough	118 mL in 1 BOTTLE	SOLUTION	118 mL	12.5 mg in 10mL	1
69536-345-04	DimetappCold and Cough and Nighttime Cold and Cough	118 mL in 1 BOTTLE	SOLUTION	118 mL	12.5 mg in 10mL	1
69536-345-04	DimetappNighttime Cold and Cough	118 mL in 1 BOTTLE	SOLUTION	118		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69536-345	DIMETAPP COLD AND COUGH AND DIMETAPP NIGHTTIME COLD AND COUGH (BROMPHIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND DIPHENHYDRAMINE HYRDOCHLORIDE) KIT [FOUNDATION CONSUMER HEALTHCARE]	1	Current NDC	20240601_1820e7c7-bc11-9061-e063-6394a90ae581.zip
69536-345	DIMETAPP COLD AND COUGH AND NIGHTTIME COLD AND COUGH (DIPHENHYDRAMINE HYDROCHLORIDE, BROMPHENIRAMINE MALEATE, AND DEXTROMETHORPHAN HYDROBROMIDE) KIT [FOUNDATION CONSUMER HEALTHCARE]	1	Current NDC	20240601_179259a9-231e-df03-e063-6294a90a145e.zip
69536-345	DIMETAPP NIGHTTIME COLD AND COUGH (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [FOUNDATION CONSUMER HEALTHCARE]	1	Current NDC, 2 package rows	20240601_179115ad-d610-99b2-e063-6294a90ae711.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 63 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Conex	DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HCL	Llorens Pharmaceutical International Division	2a343656-ac6d-8b20-e063-6294a90ab319	2025-12-31	Warnings	Exact identifier application number: M012
Dologesic NF	ACETAMINOPHEN, DEXBROMPHENIRAMINE MALEATE	Llorens Pharmaceutical International Division	974fc0d5-7a99-46fb-af38-b91240f728fa	2025-12-31	Warnings	Exact identifier application number: M012
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

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
2683422	{1 (brompheniramine maleate 0.2 MG/ML / dextromethorphan hydrobromide 1 MG/ML Oral Solution) / 1 (diphenhydramine hydrochloride 1.25 MG/ML Oral Solution) } Pack	GPCK	1820e7c7-bc11-9061-e063-6394a90ae581	1
2683422	{1 (brompheniramine maleate 0.2 MG/ML / dextromethorphan hydrobromide 1 MG/ML Oral Solution) / 1 (diphenhydramine hydrochloride 1.25 MG/ML Oral Solution) } Pack	GPCK	179259a9-231e-df03-e063-6294a90a145e	1
2683422	1 daytime (brompheniramine maleate 2 MG / dextromethorphan HBr 10 MG in 10 mL Oral Solution) / 1 nighttime (diphenhydrAMINE HCl 12.5 MG in 10 mL Oral Solution) Pack	PSN	1820e7c7-bc11-9061-e063-6394a90ae581	1
2683422	1 daytime (brompheniramine maleate 2 MG / dextromethorphan HBr 10 MG in 10 mL Oral Solution) / 1 nighttime (diphenhydrAMINE HCl 12.5 MG in 10 mL Oral Solution) Pack	PSN	179259a9-231e-df03-e063-6294a90a145e	1
2683421	brompheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG in 10 mL Oral Solution	PSN	1820e7c7-bc11-9061-e063-6394a90ae581	1
2683421	brompheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG in 10 mL Oral Solution	PSN	179259a9-231e-df03-e063-6294a90a145e	1
1049884	diphenhydrAMINE HCl 50 MG in 40 mL Oral Solution	PSN	179115ad-d610-99b2-e063-6294a90ae711	1
1049884	diphenhydrAMINE HCl 50 MG in 40 mL Oral Solution	PSN	1820e7c7-bc11-9061-e063-6394a90ae581	1
1049884	diphenhydrAMINE HCl 50 MG in 40 mL Oral Solution	PSN	179259a9-231e-df03-e063-6294a90a145e	1
2683421	brompheniramine maleate 0.2 MG/ML / dextromethorphan hydrobromide 1 MG/ML Oral Solution	SCD	179259a9-231e-df03-e063-6294a90a145e	1
2683421	brompheniramine maleate 0.2 MG/ML / dextromethorphan hydrobromide 1 MG/ML Oral Solution	SCD	1820e7c7-bc11-9061-e063-6394a90ae581	1
1049884	diphenhydramine hydrochloride 1.25 MG/ML Oral Solution	SCD	179259a9-231e-df03-e063-6294a90a145e	1
1049884	diphenhydramine hydrochloride 1.25 MG/ML Oral Solution	SCD	1820e7c7-bc11-9061-e063-6394a90ae581	1
1049884	diphenhydramine hydrochloride 1.25 MG/ML Oral Solution	SCD	179115ad-d610-99b2-e063-6294a90ae711	1
2683422	1 daytime (brompheniramine maleate 2 MG / dextromethorphan HBr 10 MG per 10 mL Oral Solution) / 1 nighttime (diphenhydramine HCl 12.5 MG per 10 mL Oral Solution) Pack	SY	179259a9-231e-df03-e063-6294a90a145e	1
2683422	1 daytime (brompheniramine maleate 2 MG / dextromethorphan HBr 10 MG per 10 mL Oral Solution) / 1 nighttime (diphenhydramine HCl 12.5 MG per 10 mL Oral Solution) Pack	SY	1820e7c7-bc11-9061-e063-6394a90ae581	1
2683421	brompheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG per 10 ML Oral Solution	SY	179259a9-231e-df03-e063-6294a90a145e	1
2683421	brompheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG per 10 ML Oral Solution	SY	1820e7c7-bc11-9061-e063-6394a90ae581	1
1049884	diphenhydramine hydrochloride 50 MG per 40 ML Oral Solution	SY	179259a9-231e-df03-e063-6294a90a145e	1
1049884	diphenhydramine hydrochloride 50 MG per 40 ML Oral Solution	SY	179115ad-d610-99b2-e063-6294a90ae711	1
1049884	diphenhydramine hydrochloride 50 MG per 40 ML Oral Solution	SY	1820e7c7-bc11-9061-e063-6394a90ae581	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
69536-345-04	69536034504	1 BOTTLE in 1 CARTON (69536-345-04) / 118 mL in 1 BOTTLE	1 bottle	2024-06-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Dimetapp ® Nighttime Cold and Cough	Foundation Consumer Healthcare	2024-06-01	HUMAN OTC DRUG LABEL	1
Dimetapp Cold and Cough and Nighttime Cold and Cough	Foundation Consumer Healthcare	2024-06-01	HUMAN OTC DRUG LABEL	1
Dimetapp Cold and Cough and Dimetapp Nighttime Cold and Cough	Foundation Consumer Healthcare	2024-06-01	HUMAN OTC DRUG LABEL	1