Dimetapp

Product NDC: 80070-340
11-digit product format: 800700340
Labeler code: 80070
Product ID: 80070-340_4b837950-3c27-be85-e063-6294a90ab6b6
Type: HUMAN OTC DRUG
Nonproprietary name: DIPHENHYDRAMINE HYDROCHLORIDE and PHENYLEPHRINE HYDROCHLORIDE
Dosage form: SOLUTION
Route: ORAL
Labeler: Foundation Consumer Brands
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2021-09-15
Marketing end: 2026-12-31
Substance: DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength: 6.25; 2.5 mg/5mL; mg/5mL
Pharmacologic classes: Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], 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: Nighttime Cold and Congestion

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DIPHENHYDRAMINE HYDROCHLORIDE	6.25 mg/5mL
PHENYLEPHRINE HYDROCHLORIDE	2.5 mg/5mL

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
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
1236048	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
96a1055f-e831-4f4b-8af3-7a41838c194c	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
80070-340-04	Dimetapp Cold and Cough and Nighttime Cold and Congestion	1 in 1 CARTON	SOLUTION		6.25 mg in 5mL	7
80070-340-04	Dimetapp Cold and Cough and Nighttime Cold and Congestion	118 mL in 1 BOTTLE	SOLUTION	118 mL	2.5 mg in 5mL	7
80070-340-04	Dimetapp Cold and Cough and Dimetapp Nighttime Cold and Congestion	118 mL in 1 BOTTLE	SOLUTION	118 mL	6.25 mg in 5mL	5
80070-340-04	Dimetapp Cold and Cough and Dimetapp Nighttime Cold and Congestion	1 in 1 CARTON	SOLUTION		2.5 mg in 5mL	5
80070-340-04	DimetappNighttime Cold and Congestion	118 mL in 1 BOTTLE	SOLUTION	118		4
80070-340-04	DimetappNighttime Cold and Congestion	1 in 1 CARTON	SOLUTION	1		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
80070-340	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
80070-340	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
80070-340	DIMETAPP NIGHTTIME COLD AND CONGESTION (DIPHENHYDRAMINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [FOUNDATION CONSUMER BRANDS]	3	Current NDC, Legacy NDC, 2 package rows	20231107_96a1055f-e831-4f4b-8af3-7a41838c194c.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 119 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
nasal decongestant	OXYMETAZOLINE HYDROCHLORIDE	Safeway	f1d0edd5-fe58-4de0-98f4-07fb24bd0ac2	2025-02-19	Warnings	Exact identifier application number: M012
Coricidin HBP Cold and Flu	ACETAMINOPHEN AND CHLORPHENIRAMINE MALEATE	Bayer HealthCare LLC.	763a5334-a741-4678-9947-603776622450	2025-02-18	Warnings	Exact identifier application number: M012
Sof Skin Vaporizing Chest Rub and Cough Suppressant	MENTHOL AND CAMPHOR AND EUCALYPTUS OIL	Viny Health and Beauty Inc	46ae16a4-b8a7-44de-ae1a-9bb503c15ea0	2025-02-18	Warnings	Exact identifier application number: M012
Pain Reliever PM	ACETAMINOPHEN DIPHENHYDRAMINE HCL	QUALITY CHOICE (Chain Drug Marketing Association)	4897d1df-4fb3-46e2-bbf0-847e964dca0a	2025-02-18	Warnings	Exact identifier application number: M012
meijer EXTRA STRENGTH Pain Relief PM Caplet	ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE	Meijer, Inc.	1bee7e4f-1813-1bdf-e063-6294a90a6a32	2025-02-17	Warnings	Exact identifier application number: M012
ACETAMINOPHEN, DEXTROMETHORPHAN HBr, GUAILFENESIN,PHENLYEPHRINE HCL	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAILFENESIN,PHENLYEPHRINE HCL	Kroger Company	a24f09d9-60f1-853a-e053-2a95a90ae1fa	2025-02-15	Warnings	Exact identifier application number: M012
MAXIMUM STRENGTH COLD AND FLU	ACETAMINOPHEN,DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	FAMILY DOLLAR SERVICES	a7343bea-53cc-4621-e053-2a95a90a2a5f	2025-02-15	Warnings	Exact identifier application number: M012
MAXIMUM STRENGTH DAY-NIGHT COLD AND FLU FORMULA	ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE HCL	FAMILY DOLLAR	aa8f6dd0-d19f-0c10-e053-2a95a90a1e8a	2025-02-15	Warnings	Exact identifier application number: M012
MAXIMUM STRENGHT DAY COLD AND FLU FORMULA	ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE HCL	FAMILY DOLLAR	aa8ebccf-6813-2dca-e053-2a95a90a032b	2025-02-15	Warnings	Exact identifier application number: M012
MAXIMUM STRENTH NIGHT COLD AND FLU FORMULA	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	FAMILY DOLLAR	aa8f0465-1595-0b0f-e053-2a95a90a0081	2025-02-15	Warnings	Exact identifier application number: M012
DAYTIME SEVERE COLD AND FLU	ACETAMINOPHEN, PHENYLEPHRINE HCL, DEXTROMETHORPHAN HBR, GUAIFENESIN	KROGER COMPANY	9bb7aaf0-6698-9a5c-e053-2a95a90a097c	2025-02-14	Warnings	Exact identifier application number: M012
Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	H-E-B	db432947-fe02-79b2-e053-2a95a90af4a9	2025-02-14	Warnings	Exact identifier application number: M012
Halls Sugar Free Cherry	MENTHOL	Mondelez Global LLC	ea8dfe96-f6a4-4172-bf9e-ae3cf606ff50	2025-02-14	Warnings	Exact identifier application number: M012
Halls Sugar Free Watermelon	MENTHOL	Mondelez Global LLC	c4c090ca-f083-74e0-e053-2a95a90a9d60	2025-02-14	Warnings	Exact identifier application number: M012
Tukol Max Action	OXYMETAZOLINE HYDROCHLORIDE	Genomma Lab USA	73358103-43dc-4b11-9c89-9a6ba45bf1af	2025-02-14	Warnings	Exact identifier application number: M012
Maximum Strength Mucus Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Chain Drug Marketing Association Inc.	6c4e867b-24b9-4525-9fab-10f1e7910b13	2025-02-13	Warnings	Exact identifier application number: M012
DAYTIME- NIGHTTIME COLD AND FLU	DAYTIME NIGHTTIME COLD AND FLU	TARGET CORP	9def204a-ee1e-6868-e053-2995a90a76b8	2025-02-13	Warnings	Exact identifier application number: M012
Daytime Cold and Flu and Nigttime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	BETTER LIVING BRANDS LLC.	f2c11b63-278f-64de-e053-2995a90a5aae	2025-02-12	Warnings	Exact identifier application number: M012
Daytime Cold and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	BETTER LIVING BRANDS LLC.	f29c604a-271d-a702-e053-2a95a90a3427	2025-02-12	Warnings	Exact identifier application number: M012
Nighttime cold and flu relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	BETTER LIVING BRANDS LLC.	f2c01090-645c-1efe-e053-2995a90a7df5	2025-02-12	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
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	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	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 2 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG per 10 ML Oral Solution	SY	42720fa0-fcdd-4614-80b2-16d0ada345b1	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
1236048	diphenhydrAMINE HCl 6.25 MG / phenylephrine HCl 2.5 MG in 5 mL Oral Solution	PSN	96a1055f-e831-4f4b-8af3-7a41838c194c	4
1236048	diphenhydramine hydrochloride 1.25 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution	SCD	96a1055f-e831-4f4b-8af3-7a41838c194c	4
1236048	diphenhydramine HCl 12.5 MG / phenylephrine HCl 5 MG per 10 ML Oral Solution	SY	96a1055f-e831-4f4b-8af3-7a41838c194c	4
1236048	diphenhydramine HCl 6.25 MG / phenylephrine HCl 2.5 MG per 5 ML Oral Solution	SY	96a1055f-e831-4f4b-8af3-7a41838c194c	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
80070-340-04	80070034004	1 BOTTLE in 1 CARTON (80070-340-04) / 118 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 ® Nighttime Cold and Congestion	Foundation Consumer Brands	2026-02-23	HUMAN OTC DRUG LABEL	4