Dimetapp

Product NDC: 80070-310
11-digit product format: 800700310
Labeler code: 80070
Product ID: 80070-310_4b829d95-1c2e-6668-e063-6294a90a45ab
Type: HUMAN OTC DRUG
Nonproprietary name: BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE
Dosage form: ELIXIR
Route: ORAL
Labeler: Foundation Consumer Brands
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2021-09-15
Marketing end: 2026-12-31
Substance: BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength: 1; 5; 2.5 mg/5mL; mg/5mL; mg/5mL
Pharmacologic classes: Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag: No
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: Cold and Cough

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BROMPHENIRAMINE MALEATE	1 mg/5mL
DEXTROMETHORPHAN HYDROBROMIDE	5 mg/5mL
PHENYLEPHRINE HYDROCHLORIDE	2.5 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
IXA7C9ZN03	Internal UNII lookup
9D2RTI9KYH	Internal UNII lookup
04JA59TNSJ	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1090463	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
cc09a8c5-d173-4261-b838-96e6a16e2ff9	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e4e263da-1c53-440f-bb80-b7a575843b5a	Product name	1	20260313
d2168cac-a261-415a-9c78-3522859fa720	Product name	3	20251124
bf324df6-7127-7deb-def5-2681c136cd03	Product name	3	20250325
05a8cdd1-eeb8-409e-b938-0778225eca7d	Product name	4	20250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9	Product name	8	20250220
0e2e0f88-b076-afe1-4bdd-32bca4375bec	Product name	3	20250127
f489e8f3-5c9e-4818-b539-a73587edcfc7	Product name	2	20240229
0f7ae452-206d-4fc4-868d-56fc47074084	Product name	1	20231011
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
b5abe2e3-39a1-43eb-9bff-f3c1653fe3df	Product name	2	20190930
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
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814	Product name	3	20150910
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
3e48c9c4-918d-5d23-2f0b-d2398b06be54	Product name	1	20140508
42f3c020-f1b3-89bc-7bdc-e1f10e680485	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
e949165d-714d-e548-2b76-0cb5def16f30	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
80070-310-04	Dimetapp Cold and Cough and Nighttime Cold and Congestion	118 mL in 1 BOTTLE	ELIXIR	118 mL	1 mg in 5mL	7
80070-310-04	Dimetapp Cold and Cough and Nighttime Cold and Congestion	1 in 1 CARTON	ELIXIR		1 mg in 5mL	7
80070-310-04	DimetappCold and Cough	118 mL in 1 BOTTLE	ELIXIR	118		5
80070-310-04	Dimetapp Cold and Cough and Dimetapp Nighttime Cold and Congestion	1 in 1 CARTON	ELIXIR		1 mg in 5mL	5
80070-310-04	Dimetapp Cold and Cough and Dimetapp Nighttime Cold and Congestion	118 mL in 1 BOTTLE	ELIXIR	236 mL	1 mg in 5mL	5
80070-310-04	DimetappCold and Cough	1 in 1 CARTON	ELIXIR	1		5
80070-310-08	DimetappCold and Cough	1 in 1 CARTON	ELIXIR	1		5
80070-310-08	DimetappCold and Cough	237 mL in 1 BOTTLE	ELIXIR	237		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
80070-310	DIMETAPP COLD AND COUGH AND NIGHTTIME COLD AND CONGESTION (DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE, BROMPHENIRAMINE MALEATE, AND DEXTROMETHORPHAN HYDROBROMIDE) KIT [FOUNDATION CONSUMER BRANDS]	6	Current NDC, Legacy NDC	20240117_1fbe1ce0-5e3e-4af5-a5f1-85ed12ced246.zip
80070-310	DIMETAPP COLD AND COUGH (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) ELIXIR [FOUNDATION CONSUMER BRANDS]	4	Current NDC, Legacy NDC, 4 package rows	20241218_cc09a8c5-d173-4261-b838-96e6a16e2ff9.zip
80070-310	DIMETAPP COLD AND COUGH AND DIMETAPP NIGHTTIME COLD AND CONGESTION (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND DIPHENHYDRAMINE HYRDOCHLORIDE) KIT [FOUNDATION CONSUMER BRANDS]	4	Current NDC, Legacy NDC	20240119_42720fa0-fcdd-4614-80b2-16d0ada345b1.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 57 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Walgreens NightTime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE	WALGREEN COMPANY	5bf72e2f-15c8-466a-9e13-50654233da91	2026-01-19	Warnings	Exact identifier application number: M012
Cold and Flu Daytime, Nighttime, Multi-Symptom	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Walgreens	9862f84d-1c18-4ef7-86dc-98572599d417	2026-01-19	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	Walgreens	37853689-c9ca-4bc7-9c5b-4a68b8d778be	2026-01-19	Warnings	Exact identifier application number: M012
VAPORX	CAMPHOR (SYNTHETIC), EUCALYPTUS OIL, AND MENTHOL	AKRON PHARMA INC	51b32162-0c5a-4b5b-999a-34337d816603	2026-01-19	Warnings	Exact identifier application number: M012
Equate	OXYMETAZOLINE HCL	Walmart Inc	2f762c24-2442-506a-e063-6394a90a3b96	2026-01-19	Warnings	Exact identifier application number: M012
Dimetane	DIPHENHYDRAMINE HYDROCHLORIDE	Rising Pharma Holdings, Inc.	484d6a37-b84e-4ead-bb89-9c3d8c3bcd2f	2026-01-19	Warnings	Exact identifier application number: M012
nitetime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Publix Super Markets Inc	f681d986-9838-42d8-8ed9-732a39fbf870	2026-01-19	Warnings	Exact identifier application number: M012
Nasal Decongestant	PSEUDOEPHEDRINE HCL	H E B	22d241c5-a3fd-4619-8147-91d7a4c8cf98	2026-01-19	Warnings	Exact identifier application number: M012
Nasal Decongestant Maximum Strength	PSEUDOEPHEDRINE HCL	Better Living Brands, LLC	9fe63ca6-3863-4175-9aec-ecd6ebbdb249	2026-01-19	Warnings	Exact identifier application number: M012
Good Neighbor Pharmacy Night Time	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Amerisource Bergen	5749ce9d-e182-478f-ab88-b520a35a99a7	2026-01-19	Warnings	Exact identifier application number: M012
Foster and Thrive Daytime Cold and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE	Strategic Sourcing Services LLC	1d9150b1-2f6c-4c33-8c93-3ed1d88585e2	2026-01-18	Warnings	Exact identifier application number: M012
HealthWise Chest Rub	CAMPHOR (SYNTHETIC), EUCALYPTUS OIL, AND MENTHOL	Veridian Healthcare	ce3ceffd-3ff5-3795-e053-2995a90a827f	2026-01-18	Warnings	Exact identifier application number: M012
topcare nite time cold and flu relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Topco Associates LLC	31210a95-f9dc-49db-aab5-25c4dca49266	2026-01-17	Warnings	Exact identifier application number: M012
Vicks DayQuil HOT REMEDY RAPID RELIEF MULTI-SYMPTOM Cold and Flu plus Congestion	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Procter & Gamble Manufactura S de RL de CV	f77226c0-b6d5-9fd0-e053-6294a90a4b57	2026-01-16	Warnings	Exact identifier application number: M012
Vicks DayQuil NyQuil HOT REMEDY RAPID RELIEF MULTI-SYMPTOM Cold and Flu plus Congestion	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL	Procter & Gamble Manufactura S de RL de CV	f691734b-5cf4-6eb8-e053-2a95a90aee80	2026-01-16	Warnings	Exact identifier application number: M012
Vicks NyQuil HOT REMEDY RAPID RELIEF MULTI-SYMPTOM Cold and Flu plus Congestion	ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL	Procter & Gamble Manufactura S de RL de CV	f771aa19-295a-9f4e-e053-6294a90a1674	2026-01-16	Warnings	Exact identifier application number: M012
CVS Cherry Cough Drops	MENTHOL	CVS Pharmacy	de5c4b94-0420-5d43-e053-2995a90aa5a5	2026-01-16	Warnings	Exact identifier application number: M012
CVS Honey Lemon Cough Drops	MENTHOL	CVS Pharmacy	de963dc3-8108-440f-e053-2995a90a906f	2026-01-16	Warnings	Exact identifier application number: M012
CVS SF Menthol Cough Drops	MENTHOL	CVS Pharmacy	e08f8ca3-b683-4964-e053-2a95a90afabb	2026-01-16	Warnings	Exact identifier application number: M012
CVS SF Honey Lemon Cough Drops	MENTHOL	CVS Pharmacy	e0cdeccf-c32f-318a-e053-2a95a90ac401	2026-01-16	Warnings	Exact identifier application number: M012

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
IXA7C9ZN03	BROMPHENIRAMINE MALEATE	980-71-2	BROMPHENIRAMINE MALEATE
9D2RTI9KYH	DEXTROMETHORPHAN HYDROBROMIDE	6700-34-1	DEXTROMETHORPHAN HYDROBROMIDE
04JA59TNSJ	PHENYLEPHRINE HYDROCHLORIDE	61-76-7	PHENYLEPHRINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1666116	{1 (brompheniramine maleate 0.2 MG/ML / dextromethorphan hydrobromide 1 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution) / 1 (diphenhydramine hydrochloride 1.25 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution) } Pack	GPCK	1fbe1ce0-5e3e-4af5-a5f1-85ed12ced246	7
1666116	1 daytime (brompheniramine maleate 1 MG / dextromethorphan HBr 5 MG / phenylephrine HCl 2.5 MG in 5 mL Oral Solution) / 1 nighttime (diphenhydrAMINE HCl 6.25 MG / phenylephrine HCl 2.5 MG in 5 mL Oral Solution) Pack	PSN	1fbe1ce0-5e3e-4af5-a5f1-85ed12ced246	7
1090463	brompheniramine maleate 1 MG / dextromethorphan HBr 5 MG / phenylephrine HCl 2.5 MG in 5 mL Oral Solution	PSN	1fbe1ce0-5e3e-4af5-a5f1-85ed12ced246	7
1236048	diphenhydrAMINE HCl 6.25 MG / phenylephrine HCl 2.5 MG in 5 mL Oral Solution	PSN	1fbe1ce0-5e3e-4af5-a5f1-85ed12ced246	7
1090463	brompheniramine maleate 0.2 MG/ML / dextromethorphan hydrobromide 1 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution	SCD	1fbe1ce0-5e3e-4af5-a5f1-85ed12ced246	7
1236048	diphenhydramine hydrochloride 1.25 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution	SCD	1fbe1ce0-5e3e-4af5-a5f1-85ed12ced246	7
1666116	1 daytime (brompheniramine maleate 1 MG / dextromethorphan HBr 5 MG / phenylephrine HCl 2.5 MG per 5 ML Oral Solution) / 1 nighttime (diphenhydrAMINE HCl 6.25 MG / phenylephrine HCl 2.5 MG per 5 ML Oral Solution) Pack	SY	1fbe1ce0-5e3e-4af5-a5f1-85ed12ced246	7
1666116	1 daytime (brompheniramine maleate 2 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG per 10 ML Oral Solution) / 1 nighttime (diphenhydrAMINE HCl 12.5 MG / phenylephrine HCl 5 MG per 10 ML Oral Solution) Pack	SY	1fbe1ce0-5e3e-4af5-a5f1-85ed12ced246	7
1090463	brompheniramine maleate 1 MG / dextromethorphan hydrobromide 5 MG / phenylephrine hydrochloride 2.5 MG per 5 ML Oral Solution	SY	1fbe1ce0-5e3e-4af5-a5f1-85ed12ced246	7
1090463	brompheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG per 10 ML Oral Solution	SY	1fbe1ce0-5e3e-4af5-a5f1-85ed12ced246	7
1236048	diphenhydramine HCl 12.5 MG / phenylephrine HCl 5 MG per 10 ML Oral Solution	SY	1fbe1ce0-5e3e-4af5-a5f1-85ed12ced246	7
1236048	diphenhydramine HCl 6.25 MG / phenylephrine HCl 2.5 MG per 5 ML Oral Solution	SY	1fbe1ce0-5e3e-4af5-a5f1-85ed12ced246	7
1666116	{1 (brompheniramine maleate 0.2 MG/ML / dextromethorphan hydrobromide 1 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution) / 1 (diphenhydramine hydrochloride 1.25 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution) } Pack	GPCK	42720fa0-fcdd-4614-80b2-16d0ada345b1	5
1666116	1 daytime (brompheniramine maleate 1 MG / dextromethorphan HBr 5 MG / phenylephrine HCl 2.5 MG in 5 mL Oral Solution) / 1 nighttime (diphenhydrAMINE HCl 6.25 MG / phenylephrine HCl 2.5 MG in 5 mL Oral Solution) Pack	PSN	42720fa0-fcdd-4614-80b2-16d0ada345b1	5
1090463	brompheniramine maleate 1 MG / dextromethorphan HBr 5 MG / phenylephrine HCl 2.5 MG in 5 mL Oral Solution	PSN	cc09a8c5-d173-4261-b838-96e6a16e2ff9	5
1090463	brompheniramine maleate 1 MG / dextromethorphan HBr 5 MG / phenylephrine HCl 2.5 MG in 5 mL Oral Solution	PSN	42720fa0-fcdd-4614-80b2-16d0ada345b1	5
1236048	diphenhydrAMINE HCl 6.25 MG / phenylephrine HCl 2.5 MG in 5 mL Oral Solution	PSN	42720fa0-fcdd-4614-80b2-16d0ada345b1	5
1090463	brompheniramine maleate 0.2 MG/ML / dextromethorphan hydrobromide 1 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution	SCD	cc09a8c5-d173-4261-b838-96e6a16e2ff9	5
1090463	brompheniramine maleate 0.2 MG/ML / dextromethorphan hydrobromide 1 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution	SCD	42720fa0-fcdd-4614-80b2-16d0ada345b1	5
1236048	diphenhydramine hydrochloride 1.25 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution	SCD	42720fa0-fcdd-4614-80b2-16d0ada345b1	5
1666116	1 daytime (brompheniramine maleate 1 MG / dextromethorphan HBr 5 MG / phenylephrine HCl 2.5 MG per 5 ML Oral Solution) / 1 nighttime (diphenhydrAMINE HCl 6.25 MG / phenylephrine HCl 2.5 MG per 5 ML Oral Solution) Pack	SY	42720fa0-fcdd-4614-80b2-16d0ada345b1	5
1666116	1 daytime (brompheniramine maleate 2 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG per 10 ML Oral Solution) / 1 nighttime (diphenhydrAMINE HCl 12.5 MG / phenylephrine HCl 5 MG per 10 ML Oral Solution) Pack	SY	42720fa0-fcdd-4614-80b2-16d0ada345b1	5
1090463	brompheniramine maleate 1 MG / dextromethorphan hydrobromide 5 MG / phenylephrine hydrochloride 2.5 MG per 5 ML Oral Solution	SY	42720fa0-fcdd-4614-80b2-16d0ada345b1	5
1090463	brompheniramine maleate 1 MG / dextromethorphan hydrobromide 5 MG / phenylephrine hydrochloride 2.5 MG per 5 ML Oral Solution	SY	cc09a8c5-d173-4261-b838-96e6a16e2ff9	5
1090463	brompheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG per 10 ML Oral Solution	SY	42720fa0-fcdd-4614-80b2-16d0ada345b1	5
1090463	brompheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG per 10 ML Oral Solution	SY	cc09a8c5-d173-4261-b838-96e6a16e2ff9	5
1236048	diphenhydramine HCl 12.5 MG / phenylephrine HCl 5 MG per 10 ML Oral Solution	SY	42720fa0-fcdd-4614-80b2-16d0ada345b1	5
1236048	diphenhydramine HCl 6.25 MG / phenylephrine HCl 2.5 MG per 5 ML Oral Solution	SY	42720fa0-fcdd-4614-80b2-16d0ada345b1	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
80070-310-04	80070031004	1 BOTTLE in 1 CARTON (80070-310-04) / 118 mL in 1 BOTTLE	1 bottle	2021-09-15	2026-12-31	No	No	Current
80070-310-08	80070031008	1 BOTTLE in 1 CARTON (80070-310-08) / 237 mL in 1 BOTTLE	1 bottle	2021-09-15	2026-12-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Dimetapp Cold and Cough and Nighttime Cold and Congestion	Foundation Consumer Brands	2026-02-23	HUMAN OTC DRUG LABEL	7
Dimetapp ® Cold and Cough and Dimetapp ® Nighttime Cold and Congestion	Foundation Consumer Brands	2026-02-23	HUMAN OTC DRUG LABEL	5
Dimetapp ® Cold and Cough	Foundation Consumer Brands	2026-02-23	HUMAN OTC DRUG LABEL	5