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 33 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Halls Variety Pack Mentholyptus Honey Lemon Cherry	MENTHOL	Mondelez Global LLC	512a9a2e-6160-80d1-e063-6394a90aeff0	2026-05-08	Warnings	Exact identifier application number: M012
ALKA SELTZER COLD Cold Flu and Congestion Severe Night Fast Gels	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Bayer HealthCare LLC.	5150ff85-85bb-9cd9-e063-6294a90a1144	2026-05-08	Warnings	Exact identifier application number: M012
Dr. Simi Children s Cough	DEXTROMETHORPHAN HBR, GUAIFENESIN	Farmacias De Similares TX LLC	5151740a-8270-7bb5-e063-6294a90ae387	2026-05-08	Warnings	Exact identifier application number: M012
Kids Allergy	DIPHENHYDRAMINE HCL	Genexa Inc.	a7bc5f7c-eaeb-25d0-e053-2a95a90a9ec4	2026-05-08	Warnings	Exact identifier application number: M012
day time non drowsy	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Publix Super Markets Inc	f4fd597f-bca2-4ed4-b353-6c734f2f885c	2026-05-08	Warnings	Exact identifier application number: M012
Daytime Non Drowsy	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	CVS Pharmacy	d8339bb0-5da3-4f34-a819-339643cf4a97	2026-05-08	Warnings	Exact identifier application number: M012
severe tussin cf	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	a26afc33-533e-4dc0-ab25-21be87356e22	2026-05-08	Warnings	Exact identifier application number: M012
SEVERE CONGESTION and COUGH MAX	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	DeMoulas Market Basket	cdd53eba-1fa2-49c1-b03d-c32f309da7fb	2026-05-08	Warnings	Exact identifier application number: M012
Benadryl Allergy Liqui-Gels	DIPHENHYDRAMINE HYDROCHLORIDE	Kenvue Brands LLC	bfeae100-e2d1-4607-be3b-2d9b15cd4f7f	2026-05-07	Warnings	Exact identifier application number: M012
Chest Rub	CAMPHOR, EUCALYPTUS OIL, MENTHOL	H E B	6503761f-37ae-4f39-b727-cb75d4c4a3c9	2026-05-07	Warnings, Adverse reactions	Exact identifier application number: M012
Mucus Relief Severe Congestion and Cough	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	TOPCO ASSOCIATES LLC	ad199488-a4be-4b6e-b806-67ce8a6e907e	2026-05-07	Warnings	Exact identifier application number: M012
good sense nasal	OXYMETAZOLINE HCL	L. Perrigo Company	5d42adb9-3625-4072-a6b1-29a229f255c8	2026-05-07	Warnings	Exact identifier application number: M012
Childrens Allergy Relief	DIPHENHYDRAMINE HCL	Walgreen Company	4856cd7b-ccdf-4546-9c65-236ebaac3dca	2026-05-06	Warnings	Exact identifier application number: M012
Mucus Relief All in One Maximum Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	0f8928a1-97ef-4128-b8d2-20bdb6e5b6ac	2026-05-06	Warnings	Exact identifier application number: M012
daytime cough and chest congestion dm	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	175cc2d0-0202-4e38-8af2-9fc126b7412d	2026-05-06	Warnings	Exact identifier application number: M012
Nasal Decongestant PE	PHENYLEPHRINE HYDROCHLORIDE	HHH Pharmaceuticals	90fae0fa-da07-4ea8-bdbd-39c2ed99ae59	2026-05-06	Warnings	Exact identifier application number: M012
PHENYLEPHRINE HYDROCHLORIDE	PHENYLEPHRINE HYDROCHLORIDE	HHH Pharmaceuticals	5d8b980f-0011-41e3-a881-ad10fe399079	2026-05-06	Warnings	Exact identifier application number: M012
HALLS Mentholyptus	MENTHOL	Mondelez Global LLC	38d12374-e2c7-444c-e063-6294a90a42b3	2026-05-06	Warnings	Exact identifier application number: M012
HALLS Mentholyptus	MENTHOL	Mondelez Global LLC	1ab295ff-94b1-c938-e063-6294a90a98fd	2026-05-06	Warnings	Exact identifier application number: M012
ALKA SELTZER COLD Cold and Sinus Maximum Strength Fast Gels	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE , PHENYLEPHRINE HYDROCHLORIDE	Bayer HealthCare LLC.	512af63d-2f09-4baa-e063-6394a90a86bd	2026-05-06	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