NDC 0067-7918-01 - Theraflu Multi-Symptom Severe Cold and Theraflu Nighttime Severe Cold and Cough

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC: 0067-7918
Requested NDC: 0067-7918-01
Package NDCs from labels: 0067-7918-01, 0067-7918-06
Manufacturer: Haleon US Holdings LLC
Effective date: 2024-04-10
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
THERAFLU MULTI-SYMPTOM SEVERE COLD - Haleon US Holdings LLC	Haleon US Holdings LLC	2024-04-10	HUMAN OTC DRUG LABEL
THERAFLU NIGHTTIME SEVERE COLD AND COUGH - Haleon US Holdings LLC	Haleon US Holdings LLC	2024-01-28	HUMAN OTC DRUG LABEL
Theraflu Nighttime Severe Cold and Cough - Select Corporation	Select Corporation	2022-05-04	HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0067-7918-01	THERAFLUNIGHTTIME SEVERE COLD AND COUGH	237 mL in 1 PACKET	POWDER, FOR SOLUTION	237		12
0067-7918-06	THERAFLUNIGHTTIME SEVERE COLD AND COUGH	6 in 1 CARTON	POWDER, FOR SOLUTION	6		12
0067-7918-01	Theraflu Multi-Symptom Severe Cold and Theraflu Nighttime Severe Cold and Cough	237 mL in 1 PACKET	POWDER, FOR SOLUTION	1422 mL	650 mg in 237mL	8
0067-7918-01	Theraflu Multi-Symptom Severe Cold and Theraflu Nighttime Severe Cold and Cough	237 mL in 1 PACKET	POWDER, FOR SOLUTION	1422 mL	650 mg in 237mL	8
0067-7918-06	Theraflu Multi-Symptom Severe Cold and Theraflu Nighttime Severe Cold and Cough	6 in 1 CARTON	POWDER, FOR SOLUTION		650 mg in 237mL	8
0067-7918-06	Theraflu Multi-Symptom Severe Cold and Theraflu Nighttime Severe Cold and Cough	6 in 1 CARTON	POWDER, FOR SOLUTION		650 mg in 237mL	8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0067-7918	THERAFLU NIGHTTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [HALEON US HOLDINGS LLC]	12	Current NDC, Legacy NDC, 2 package rows	20240129_5f7f6f70-0f36-4541-89f2-d953259cdb1e.zip
0067-7918	THERAFLU MULTI-SYMPTOM SEVERE COLD AND THERAFLU NIGHTTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, DIPHENHYDRAMINE HCL) KIT [HALEON US HOLDINGS LLC]	8	Current NDC, Legacy NDC	20240411_b06b64c5-dbb4-4ef5-af18-3d7d4979c02f.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0067-7918-01	EA - Each	0067-7918	53abe691-ab9e-417e-83a4-f095d2857a75	1	2022-06-06
0067-7918-06	EA - Each	0067-7918	bd024597-3a48-4bb9-a8d1-15d200f87b95	1	2014-08-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	THERAFLU NIGHTTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH]	3
DIPHENHYDRAMINE HYDROCHLORIDE	ACTIVE INGREDIENT	TC2D6JAD40	THERAFLU NIGHTTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH]	3
PHENYLEPHRINE HYDROCHLORIDE	ACTIVE INGREDIENT	04JA59TNSJ	THERAFLU NIGHTTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH]	3
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	THERAFLU NIGHTTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH]	3
DIPHENHYDRAMINE	ACTIVE MOIETY	8GTS82S83M	THERAFLU NIGHTTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH]	3
PHENYLEPHRINE	ACTIVE MOIETY	1WS297W6MV	THERAFLU NIGHTTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH]	3
ACESULFAME POTASSIUM	INACTIVE INGREDIENT	23OV73Q5G9	THERAFLU NIGHTTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH]	3
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	THERAFLU NIGHTTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH]	3
ASPARTAME	INACTIVE INGREDIENT	Z0H242BBR1	THERAFLU NIGHTTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH]	3
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	THERAFLU NIGHTTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH]	3
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	THERAFLU NIGHTTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH]	3
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	THERAFLU NIGHTTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH]	3
MALTODEXTRIN	INACTIVE INGREDIENT	7CVR7L4A2D	THERAFLU NIGHTTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	THERAFLU NIGHTTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH]	3
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	THERAFLU NIGHTTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH]	3
SUCROSE	INACTIVE INGREDIENT	C151H8M554	THERAFLU NIGHTTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH]	3
TRIBASIC CALCIUM PHOSPHATE	INACTIVE INGREDIENT	91D9GV0Z28	THERAFLU NIGHTTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH]	3

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 31 of 362 · 7,224 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dextromethorphan Hydrobromide and Quinidine Sulphate	DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULPHATE	Sun Pharmaceutical Industries, Inc.	92b54ac4-594e-47b8-a4d3-394a29b425f3	2026-07-08	Warnings, Adverse reactions	Exact identifier unii: 9D2RTI9KYH
GOODMEDS EXTRA STRENGTH PAIN RELIEF ACETAMINOPHEN	ACETAMINOPHEN	Cabinet Health P.B.C.	88884253-5a79-4ac1-b8ce-03966d8b509d	2026-07-08	Warnings	Exact identifier unii: 362O9ITL9D
CAREALL Hemorrhoidal	MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL	New World Imports, Inc	561c601f-c2cd-f09c-e063-6294a90adb45	2026-07-08	Warnings	Exact identifier unii: 04JA59TNSJ
DG HEALTH COUGH AND CHEST CONGESTION	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Dolgencorp Inc	5d9d57aa-e43a-4dbe-9d35-36a7b82d4e6d	2026-07-08	Warnings	Exact identifier application number: M012 unii: 9D2RTI9KYH
Childrens Allergy Relief	DIPHENHYDRAMINE HCL	Topco Associates, LLC	bfcabe02-7961-4407-a748-8cd087731398	2026-07-08	Warnings	Exact identifier application number: M012 unii: TC2D6JAD40
Aller-chlor	CHLORPHENIRAMINE MALEATE	Rugby Laboratories	04ca3806-72be-47d4-9fea-5b0dee087683	2026-07-08	Warnings	Exact identifier application number: M012
nighttime cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	24c22c9f-0c2f-46dc-850e-ed05f00d3e95	2026-07-08	Warnings	Exact identifier application number: M012 unii: 9D2RTI9KYH unii: 362O9ITL9D
NITETIME COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Meijer, Inc.	0e65c5d1-a18b-452c-9be6-8d44d34577e9	2026-07-08	Warnings	Exact identifier application number: M012 unii: 9D2RTI9KYH unii: 362O9ITL9D
Allergy Relief 4 Hour	CHLORPHENIRAMINE MALEATE	Cardinal Health 110, LLC. DBA Leader	aaecfda5-1a50-4d8a-9909-7153c1a22bda	2026-07-08	Warnings	Exact identifier application number: M012
nighttime severe cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	7cb9f378-5d64-475f-bf26-4058ba6c15b4	2026-07-08	Warnings	Exact identifier application number: M012 unii: 9D2RTI9KYH unii: 04JA59TNSJ unii: 362O9ITL9D
DG HEALTH DAY TIME INTENSE FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE	Dolgencorp Inc	f174d08e-3335-4cc9-8766-4070f18c4f31	2026-07-08	Warnings	Exact identifier application number: M012 unii: 9D2RTI9KYH unii: 362O9ITL9D
Mucus Relief	GUAIFENESIN 400 MG	Health Pharma USA LLC	d60a3e9d-e88e-3b19-e053-2995a90a3e8d	2026-07-07	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	Health Pharma USA LLC	d38f47ea-7fda-170b-e053-2995a90adc82	2026-07-07	Warnings	Exact identifier application number: M012 unii: TC2D6JAD40
Nighttime Sleep Aid	DIPHENHYDRAMINE HCL 25 MG	Health Pharma USA LLC	d659f747-9790-8bd6-e053-2995a90ae793	2026-07-07	Warnings	Exact identifier unii: TC2D6JAD40
Acetaminophen	ACETAMINOPHEN	Health Pharma USA LLC	671adabe-5f82-4599-a133-3f67ccb34079	2026-07-07	Warnings	Exact identifier unii: 362O9ITL9D
Guaifenesin 200mg	GUAIFENESIN	Health Pharma USA LLC	d68222f7-b796-7b27-e053-2995a90a2efe	2026-07-07	Warnings	Exact identifier application number: M012
Pain Reliever Plus	ACETAMINOPHEN, ASPIRIN, CAFFEINE	Rugby Laboratories	c3df1652-96a8-6043-e053-2995a90a2d26	2026-07-07	Warnings	Exact identifier unii: 362O9ITL9D
naproxen sodium pm	DIPHENHYDRAMINE HYDROCHLORIDE, NAPROXEN SODIUM	Meijer Distribution Inc	34d635f8-9703-4c29-92a5-85d3b47c4c93	2026-07-07	Warnings	Exact identifier unii: TC2D6JAD40
Cold and Flu Severe Day Time / Night Time	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	DOLGENCORP, LLC	acdcc6ce-c190-4de6-b126-62fe9043112e	2026-07-07	Warnings	Exact identifier application number: M012
Calmco Allergy Relief	DIPHENHYDRAMINE HCL	CalmCo LLC	471b1a43-1708-8be7-e063-6394a90a9bb7	2026-07-06	Warnings	Exact identifier application number: M012 unii: TC2D6JAD40

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.