Cold and Flu

Product NDC: 37835-526
11-digit product format: 378350526
Labeler code: 37835
Product ID: 37835-526_153d107c-82d2-4523-87dc-68aa51eed589
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl
Dosage form: SOLUTION
Route: ORAL
Labeler: Bi-Mart
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2018-06-18
Substance: ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength: 325; 10; 5 mg/15mL; mg/15mL; mg/15mL
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
Listing certified through: 2027-12-31
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	37835-526	37835-526-30	D	Discontinued by firm		2026-08-10

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

Additional Listing Data#

Finished product: Yes
Brand name base: Cold and Flu
Brand name suffix: Daytime
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ACETAMINOPHEN	325 mg/15mL
DEXTROMETHORPHAN HYDROBROMIDE	10 mg/15mL
PHENYLEPHRINE HYDROCHLORIDE	5 mg/15mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
362O9ITL9D	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
1113705	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
f27bb9d1-9880-41f6-b500-42cb5957052a	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
37835-526-02	Cold and FluDaytime	355 mL in 1 BOTTLE, PLASTIC	SOLUTION	355		11
37835-526-30	Cold and FluDaytime	354 mL in 1 BOTTLE, PLASTIC	SOLUTION	354		11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
37835-526	COLD AND FLU DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [BI-MART]	10	Current NDC, Legacy NDC, 2 package rows	20250129_f27bb9d1-9880-41f6-b500-42cb5957052a.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 1 of 195 · 3,890 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Daytime Nighttime Intense Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Walgreen Company	03aa43fd-4962-4c2c-9edd-e422a629a0e3	2026-08-06	Warnings	Exact identifier application number: M012
Allergy Multi-Symptom	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HCL	ARMY AND AIR FORCE EXCHANGE SERVICE	f311b56f-b959-4070-9b23-82c642dd98b8	2026-08-06	Warnings	Exact identifier application number: M012
Cold Relief Multi-Symptom	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	L.N.K. International, Inc.	2ed25f69-89ef-4c50-946a-7e7b9df1ca8a	2026-08-06	Warnings	Exact identifier application number: M012
Eucamint	MENTHOL, CAMPHOR	Indiana Botanic Gardens	d79bc8de-9efb-4996-a55c-accda0f8edb2	2026-08-06	Warnings	Exact identifier application number: M012
DRX CHOICE Daytime and Nighttime Cold and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, AND ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Raritan Pharmaceuticals Inc	b745f45d-2042-4daa-9932-241836d7734b	2026-08-06	Warnings	Exact identifier application number: M012
Acetaminophen, Dextromethorphan HBr	ACETAMINOPHEN, DEXTROMETHORPHAN HBR	NUVICARE LLC	6713fdff-0e4e-4a9d-b218-34f786339c57	2026-08-06	Warnings	Exact identifier application number: M012
Daytime Cold, Nighttime Cold multi-symptom	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	United Natural Foods, Inc. dba UNFI	3b462a5d-d48b-4b73-b5d4-d7944730bbdd	2026-08-06	Warnings	Exact identifier application number: M012
Sinufrin Quick Relief Decongestant	SINUFRIN	Neilmed pharmaceuticals Inc.	0c36a34e-462d-713c-e063-6294a90a1776	2026-08-05	Warnings	Exact identifier application number: M012
No Drip	OXYMETAZOLINE HYDROCHLORIDE	NeilMed Pharmaceuticals Inc	e9b799ad-9164-7f30-e053-2a95a90a00c5	2026-08-05	Warnings	Exact identifier application number: M012
DM Max	DEXTROMETHORPHAN HBR, GUAIFENESIN	Walgreen Company	78edeb7a-4712-4f04-9d76-d5b2d20ce76d	2026-08-04	Warnings	Exact identifier application number: M012
CareOne Nighttime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	American Sales Company	c9342ad2-84dc-4f4c-9b05-c6e5c1c7989e	2026-08-04	Warnings	Exact identifier application number: M012
dg health cold and flu relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Dolgencorp Inc	3d8ce88e-9f40-4b58-a811-160ddbfb8112	2026-08-04	Warnings	Exact identifier application number: M012
ValuRx Dye Free Allergy Relief	DIPHENHYDRAMINE HCL 25 MG	Shield Pharmaceuticals Corp	ca60a413-b02e-48ce-985d-4d415780c679	2026-08-04	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	Wal-Mart Stores Inc	150b68ba-3ed4-4533-9118-74e76eaf6e48	2026-08-04	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	Rite Aid Corporation	ce393bff-498b-42e6-a41c-bbfbc58fb42c	2026-08-04	Warnings	Exact identifier application number: M012
Sinus and Headache	ACETAMINOPHEN AND PHENYLEPHRINE HCL	Cardinal Health 110, LLC. DBA Leader	3b8662bf-3abb-4e54-af9c-5fa1d2e19003	2026-08-04	Warnings	Exact identifier application number: M012
Mucus Relief PE	GUAIFENESIN, PHENYLEPHRINE HCL	Walgreen Company	cb1c1922-5dc6-520d-e77e-e951726d9701	2026-08-04	Warnings	Exact identifier application number: M012
Chest Congestion Relief DM	DEXTROMETHORPHAN HBR, GUAIFENESIN	DOLGENCORP, LLC	da053bc3-e790-4ae9-a406-2629640e97e7	2026-08-04	Warnings	Exact identifier application number: M012
Cold and Flu plus Congestion Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	WALMART INC.	1236b463-0073-44b5-a516-5b7c06a40887	2026-08-04	Warnings	Exact identifier application number: M012
daytime nitetime cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Meijer Distribution Inc	80aae1c3-a616-442b-842e-177db957a69c	2026-08-04	Warnings	Exact identifier application number: M012

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
362O9ITL9D	ACETAMINOPHEN	103-90-2	ACETAMINOPHEN
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
1113705	acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG in 15 mL Oral Solution	PSN	f27bb9d1-9880-41f6-b500-42cb5957052a	11
1113705	acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution	SCD	f27bb9d1-9880-41f6-b500-42cb5957052a	11
1113705	acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG per 15 ML Oral Solution	SY	f27bb9d1-9880-41f6-b500-42cb5957052a	11
1113705	acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG per 30 ML Oral Solution	SY	f27bb9d1-9880-41f6-b500-42cb5957052a	11
1113705	APAP 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution	SY	f27bb9d1-9880-41f6-b500-42cb5957052a	11

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
37835-526-02	37835052602	355 mL in 1 BOTTLE, PLASTIC (37835-526-02)	355 ml	2023-01-06	0000-00-00	No	No	Current
37835-526-30	37835052630	354 mL in 1 BOTTLE, PLASTIC (37835-526-30)	354 ml	2018-06-18	0000-00-00	No	No	Current