Theraflu Severe Cold Relief Daytime

Product NDC: 85237-1896
11-digit product format: 852371896
Labeler code: 85237
Product ID: 85237-1896_55fc88c7-8e44-f123-e063-6294a90adcfd
Type: HUMAN OTC DRUG
Nonproprietary name: ACETAMINOPHEN, DEXTROMETHORPHAN HBr
Dosage form: POWDER, FOR SOLUTION
Route: ORAL
Labeler: Select Consumer Group
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2023-12-01
Substance: ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE
Active strength: 500; 20 mg/1; mg/1
Pharmacologic classes: Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
NDC exclude flag: No
Listing certified through: 2027-12-31
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: Theraflu Severe Cold Relief Daytime
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ACETAMINOPHEN	500 mg/1
DEXTROMETHORPHAN HYDROBROMIDE	20 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
362O9ITL9D	Internal UNII lookup
9D2RTI9KYH	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2670598	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
55fc7d6f-cc44-b4c0-e063-6294a90ae4fc	Available on FDA.report

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 162 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Halls Mentholyptus	MENTHOL	Mondelez Global LLC	f5292c5b-5608-4e13-afc2-4f3d7133da88	2024-06-25	Warnings	Exact identifier application number: M012
Halls Strawberry	MENTHOL	Mondelez Global LLC	75638f29-7f2a-46b0-b8a0-e87bc7d6eba1	2024-06-25	Warnings	Exact identifier application number: M012
Good Sense Nasal Decongestant PE	PHENYLEPHRINE HYDROCHLORIDE	A-S Medication Solutions	5396a9cf-16eb-4628-9432-f49c67ffe2ce	2024-06-25	Warnings	Exact identifier application number: M012
Nighttime Cold and Flu Liquid	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	TARGET CORPORATION	130ca5f1-2951-ec6f-e063-6394a90a754f	2024-06-24	Warnings	Exact identifier application number: M012
Daytime and Nighttime Severe Honey Cold and Flu	DAYTIME - ACETAMINOPHEN. DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL AND NIGHTIME - ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, DOXYLAMINE SUCCINATE	TARGET CORPORATION	08fd1513-30ab-15da-e063-6394a90ab57d	2024-06-21	Warnings	Exact identifier application number: M012
Daytime Severe and Nighttime Severe cold and flu	DAYTIME SEVERE - ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, NIGHTTIME SEVERE-ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	TARGET CORPORATION	0c0caa59-0637-bc33-e063-6294a90ae244	2024-06-21	Warnings	Exact identifier application number: M012
Halls Strawberry	MENTHOL	Mondelez Global LLC	de401eb4-3282-4298-8a51-15d268253464	2024-06-21	Warnings	Exact identifier application number: M012
Cough and Chest Congestion DM Maximum Strength	DEXTROMETHORPHAN HBR, GUAIFENESIN	Walgreens	e4515d0e-c12b-40cd-8218-6d91476cfebd	2024-06-21	Warnings	Exact identifier application number: M012
SUDOGEST	PSEUDOEPHEDRINE HCL	A-S Medication Solutions	1811199f-bf88-475f-8f94-b372db4bead3	2024-06-20	Warnings	Exact identifier application number: M012
Theraflu Severe Cold Relief Soft Chews	ACETAMINOPHEN, DEXTROMETHORPHAN HBR	Haleon US Holdings LLC	91dbb541-6a86-4803-a1fe-1bf61b457c34	2024-06-19	Warnings	Exact identifier application number: M012
Tukol Max Action Cold, Flu and Sore Throat	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Genomma Lab USA	aedce1f9-4902-4c51-92e0-6056196394c2	2024-06-14	Warnings	Exact identifier application number: M012
Daytime Nighttime Cold Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	United Natural Foods, Inc. dba UNFI	dbc71f58-0704-4d2b-aed1-0dc01f980006	2024-06-11	Warnings	Exact identifier application number: M012
Nighttime Sleep Aid	DIPHENHYDRAMINE HYDROCHLORIDE	TARGET CORPORATION	135d2212-2122-b7a1-e063-6294a90aa5f5	2024-06-07	Warnings	Exact identifier application number: M012
up and up daytime honey cold flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Target Corporation	29da4b94-8f8e-48e8-909f-8476e3b39d78	2024-06-06	Warnings	Exact identifier application number: M012
Multi Symptom Cold and Multi Symptom Nighttime Cold Childrens	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI, ACETAMINOPHEN, DIPHENHYDRAMINE HCI, PHENYLEPHRINE HCI	TARGET Corporation	e3da3003-88e3-4431-8b65-e61e17728901	2024-06-04	Warnings	Exact identifier application number: M012
Dimetapp Cold and Allergy	BROMPHENIRAMINE MALEATE	Foundation Consumer Healthcare	15c3570c-bd00-8e43-e063-6294a90a8683	2024-06-01	Warnings	Exact identifier application number: M012
Dimetapp Cold and Cough	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE	Foundation Consumer Healthcare	176be362-5237-edd8-e063-6294a90a4aef	2024-06-01	Warnings	Exact identifier application number: M012
Dimetapp Nighttime Cold and Cough	DIPHENHYDRAMINE HYDROCHLORIDE	Foundation Consumer Healthcare	179115ad-d610-99b2-e063-6294a90ae711	2024-06-01	Warnings	Exact identifier application number: M012
Dimetapp Cold and Cough and Nighttime Cold and Cough	DIPHENHYDRAMINE HYDROCHLORIDE, BROMPHENIRAMINE MALEATE, AND DEXTROMETHORPHAN HYDROBROMIDE	Foundation Consumer Healthcare	179259a9-231e-df03-e063-6294a90a145e	2024-06-01	Warnings	Exact identifier application number: M012
Dimetapp Cold and Cough and Dimetapp Nighttime Cold and Cough	BROMPHIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND DIPHENHYDRAMINE HYRDOCHLORIDE	Foundation Consumer Healthcare	1820e7c7-bc11-9061-e063-6394a90ae581	2024-06-01	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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
85237-1896-1	85237189601	1 PACKET in 1 BLISTER PACK (85237-1896-1) / 1 POWDER, FOR SOLUTION in 1 PACKET (85237-1896-0)	1 packet	2023-12-01	No	No	Current
85237-1896-3	85237189603	20 PACKET in 1 CARTON (85237-1896-3) / 1 POWDER, FOR SOLUTION in 1 PACKET (85237-1896-0)	20 packet	2023-12-01	No	No	Current