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 148 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cough and Cold XL3 Xtra	ACETAMINOPHEN CHLORPHENIRAMINE MALEATE DEXTROMETHORPHAN HYDROBROMIDE PHENYLEPHERINE HYDROCHLORIDE	Selder, S.A. de C.V.	da5b31dd-becd-471a-9392-d0ee4b8f9539	2024-10-17	Warnings	Exact identifier application number: M012
Cold Medicine XL3 FORTE	ACETAMINOPHEN CHLORPHENIRAMINE MALEATE PHENYLEPHERINE HYDROCHLORIDE	MIDWAY IMPORTING INC.	58252f15-485c-3061-e053-2a91aa0a2320	2024-10-17	Warnings	Exact identifier application number: M012
Cold Medicine XL3	ACETAMINOPHEN CHLORPHENIRAMINE MALEATE PHENYLEPHERINE HYDROCHLORIDE	Midway Importing, Inc.	e41b9beb-e274-5c02-e053-2995a90ad0f8	2024-10-17	Warnings	Exact identifier application number: M012
Allergy Multi-Symptom	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDE	STRATEGIC SOURCING SERVICES LLC	38e70a28-eff2-4a48-b829-8cd68e80beef	2024-10-17	Warnings	Exact identifier application number: M012
Mucus Relief Xpect	GUAIFENSIN, DEXTROMETHORPHAN	Midway Importing Inc.	c2c8bd26-bbf1-c2e6-e053-2995a90a86a7	2024-10-17	Warnings	Exact identifier application number: M012
Antiflu Des Cough and Flu	ACETAMINOPHEN PHENYLEPHRINE HCL CHLORPHENIRAMINE MALEATE	Productos Farmaceuticos, S.A. de C.V.	dcf3897a-a793-6df7-e053-2995a90a25f8	2024-10-17	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	FSA STORE INC.	ec6aef90-ece1-4fe6-e053-2995a90a9310	2024-10-16	Warnings	Exact identifier application number: M012
Tukol MAX ACTION Cold, Sore Throat and Cough	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Genomma Lab USA, Inc	c8eebe64-00bf-436d-a9fc-1623401bebfa	2024-10-16	Warnings	Exact identifier application number: M012
Allergy	DIPHENHYDRAMINE HYDROCHLORIDE	Discount Drug Mart	4f42c8d2-0538-4bcd-aac0-e26103a30499	2024-10-16	Warnings	Exact identifier application number: M012
Tukol MAX ACTION Severe Congestion and Cough	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Genomma Lab USA, Inc	9ac3e24a-d18a-48fc-8005-55393085d57b	2024-10-16	Warnings	Exact identifier application number: M012
Nighttime Cough	DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	45471fdd-c4cd-46ad-a932-aa37327e8a41	2024-10-16	Warnings	Exact identifier application number: M012
DG Health Cold and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Dolgencorp Inc	8cb15a8d-c836-4167-bc6b-dd20a34076e8	2024-10-16	Warnings	Exact identifier application number: M012
basic care nighttime cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Amazon.com Services LLC	f4497e56-c69d-4ae9-bd81-80bf2ee1b17f	2024-10-15	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	FOODHOLD U.S.A., LLC	8256c1fb-683d-56ab-e053-2a91aa0ac197	2024-10-15	Warnings	Exact identifier application number: M012
SINUS SEVRE	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	RETAIL BUSINESS SERVICES , LLC.	9f9586e3-a8b4-4060-e053-2995a90aa068	2024-10-15	Warnings	Exact identifier application number: M012
ALLERGY RELIEF	DIPHENHYDRAMINE HYDROCHLORIDE	RETAIL BUSINESS SERVICES , LLC.	9f95715f-63dc-6086-e053-2a95a90adb0c	2024-10-15	Warnings	Exact identifier application number: M012
Allergy MultiSymptom	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDE	RETAIL BUSINESS SERVICES , LLC.	a61636e9-8fe2-8419-e053-2a95a90a011c	2024-10-15	Warnings	Exact identifier application number: M012
SINUS AND HEADACHE	ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE	RETAIL BUSINESS SERVICES , LLC.	9f95b2e8-dea4-ef59-e053-2a95a90a0bcb	2024-10-15	Warnings	Exact identifier application number: M012
Cold Multi-Symptom Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	American Sales Company	d2dcbc7c-e66c-4922-83df-c706a37bf334	2024-10-15	Warnings	Exact identifier application number: M012
Cold and Flu Severe	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	RETAIL BUSINESS SERVICES , LLC. (	9f958d97-8dcf-332d-e053-2995a90a0a65	2024-10-15	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