NDC 0067-6426-01 - 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: 0067-6426
Requested NDC: 0067-6426-01
Package NDCs from labels: 0067-6426-01, 0067-6426-06
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 MULTI-SYMPTOM SEVERE COLD - Haleon US Holdings LLC	Haleon US Holdings LLC	2024-01-28	HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0067-6426-01	THERAFLUMULTI-SYMPTOM SEVERE COLD	237 mL in 1 PACKET	POWDER, FOR SOLUTION	237		11
0067-6426-06	THERAFLUMULTI-SYMPTOM SEVERE COLD	6 in 1 CARTON	POWDER, FOR SOLUTION	6		11
0067-6426-01	Theraflu Multi-Symptom Severe Cold and Theraflu Nighttime Severe Cold and Cough	237 mL in 1 PACKET	POWDER, FOR SOLUTION	1422 mL	500 mg in 237mL	8
0067-6426-01	Theraflu Multi-Symptom Severe Cold and Theraflu Nighttime Severe Cold and Cough	237 mL in 1 PACKET	POWDER, FOR SOLUTION	4266 mL	500 mg in 237mL	8
0067-6426-06	Theraflu Multi-Symptom Severe Cold and Theraflu Nighttime Severe Cold and Cough	6 in 1 CARTON	POWDER, FOR SOLUTION		500 mg in 237mL	8
0067-6426-06	Theraflu Multi-Symptom Severe Cold and Theraflu Nighttime Severe Cold and Cough	6 in 1 CARTON	POWDER, FOR SOLUTION		500 mg in 237mL	8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0067-6426	THERAFLU MULTI-SYMPTOM SEVERE COLD (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [HALEON US HOLDINGS LLC]	11	Current NDC, Legacy NDC, 2 package rows	20240129_a4c56ca0-7785-404b-996d-137cc135f270.zip
0067-6426	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
0067-6426-01	EA - Each	0067-6426	58cccbc7-1d11-42e3-b3cb-081fe8fafced	1	2020-09-14
0067-6426-06	EA - Each	0067-6426	c8500b3f-3199-4fa6-8abd-9dd87445b1ac	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	THERAFLU MULTI SYMPTOM SEVERE COLD (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH, INC.]	4
DEXTROMETHORPHAN HYDROBROMIDE	ACTIVE INGREDIENT	9D2RTI9KYH	THERAFLU MULTI SYMPTOM SEVERE COLD (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH, INC.]	4
PHENYLEPHRINE HYDROCHLORIDE	ACTIVE INGREDIENT	04JA59TNSJ	THERAFLU MULTI SYMPTOM SEVERE COLD (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH, INC.]	4
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	THERAFLU MULTI SYMPTOM SEVERE COLD (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH, INC.]	4
DEXTROMETHORPHAN	ACTIVE MOIETY	7355X3ROTS	THERAFLU MULTI SYMPTOM SEVERE COLD (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH, INC.]	4
PHENYLEPHRINE	ACTIVE MOIETY	1WS297W6MV	THERAFLU MULTI SYMPTOM SEVERE COLD (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH, INC.]	4
ACESULFAME POTASSIUM	INACTIVE INGREDIENT	23OV73Q5G9	THERAFLU MULTI SYMPTOM SEVERE COLD (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH, INC.]	4
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	THERAFLU MULTI SYMPTOM SEVERE COLD (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH, INC.]	4
ASPARTAME	INACTIVE INGREDIENT	Z0H242BBR1	THERAFLU MULTI SYMPTOM SEVERE COLD (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH, INC.]	4
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	THERAFLU MULTI SYMPTOM SEVERE COLD (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH, INC.]	4
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	THERAFLU MULTI SYMPTOM SEVERE COLD (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH, INC.]	4
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	THERAFLU MULTI SYMPTOM SEVERE COLD (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH, INC.]	4
MALTODEXTRIN	INACTIVE INGREDIENT	7CVR7L4A2D	THERAFLU MULTI SYMPTOM SEVERE COLD (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH, INC.]	4
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	THERAFLU MULTI SYMPTOM SEVERE COLD (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH, INC.]	4
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	THERAFLU MULTI SYMPTOM SEVERE COLD (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH, INC.]	4
SUCROSE	INACTIVE INGREDIENT	C151H8M554	THERAFLU MULTI SYMPTOM SEVERE COLD (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH, INC.]	4
TRIBASIC CALCIUM PHOSPHATE	INACTIVE INGREDIENT	91D9GV0Z28	THERAFLU MULTI SYMPTOM SEVERE COLD (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH, INC.]	4

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 52 of 359 · 7,167 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Menstrual Complete	ACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE	Meijer Distribution, Inc.	14dd377f-1d30-4991-ad29-5ed1058d4622	2026-05-18	Warnings	Exact identifier unii: 362O9ITL9D
Allergy Relief	DIPHENHYDRAMINE HCL	L.N.K. International, Inc.	38df2308-f6f9-4476-ad34-4b5bc5f9fdf2	2026-05-18	Warnings	Exact identifier application number: M012 unii: TC2D6JAD40
Allergy Plus Headache Relief	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	WALMART INC.	88e3b969-79d0-4e64-95c0-c5cfd41e365f	2026-05-18	Warnings	Exact identifier application number: M012 unii: TC2D6JAD40 unii: 362O9ITL9D
childrens Pain and Fever	ACETAMINOPHEN	Topco Associates, LLC	7f7b4377-9b40-4a12-808b-f1cd7d241b0d	2026-05-18	Warnings	Exact identifier unii: 362O9ITL9D
Allergy Relief	DIPHENHYDRAMINE HCL	L.N.K. International, Inc.	db264d2f-bf81-4da2-8595-2bfa1e4ba2f1	2026-05-18	Warnings	Exact identifier application number: M012 unii: TC2D6JAD40
Menstrual Complete	ACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE	H E B	cf228a60-4181-420f-8cb0-3db3d14a0f46	2026-05-18	Warnings	Exact identifier unii: 362O9ITL9D
equate nighttime cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Wal-Mart Stores Inc	b8fc9b0e-8ab7-46e6-9fd9-18f8d4a14b5c	2026-05-15	Warnings	Exact identifier application number: M012 unii: 9D2RTI9KYH unii: 04JA59TNSJ unii: 362O9ITL9D
Menstrual Relief	ACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE	Better Living Brands, LLC	d069487b-5856-4e3e-bc0e-5e57313c8231	2026-05-15	Warnings	Exact identifier unii: 362O9ITL9D
good neighbor pharmacy cold and cough	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Amerisource Bergen	da91e6b6-32ff-44fd-afce-33ea9549554b	2026-05-15	Warnings	Exact identifier application number: M012 unii: 9D2RTI9KYH unii: 04JA59TNSJ
Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	Cardinal Health 107, LLC	50df93bf-fe72-48f6-a02e-ea9a313d47c2	2026-05-15	Warnings, Adverse reactions	Exact identifier unii: TC2D6JAD40
Antihistamine	DIPHENHYDRAMINE HCL	Gendose Pharmaceuticals, LLC	847cdee8-410f-4ff3-9245-976ed6f4c776	2026-05-15	Warnings	Exact identifier application number: M012 unii: TC2D6JAD40
Antihistamine	DIPHENHYDRAMINE HCL	Gendose Pharmaceuticals, LLC	d3b2f300-d919-44cd-ab71-b74b5bdfd977	2026-05-15	Warnings	Exact identifier application number: M012 unii: TC2D6JAD40
ONESSIP DAY TIME KIDS COLD AND COUGH PLUS FEVER	ACETAMINOPHEN 325 MG AND DEXTROMETHORPHAN HBR 10 MG ORAL LIQUID DAY TIME KIDS	MEDWISE LIFESCIENCES INC.	51d52ce4-98c4-2b9b-e063-6294a90ade44	2026-05-15	Warnings	Exact identifier application number: M012 unii: 9D2RTI9KYH unii: 362O9ITL9D
Curewell Tussin DM	DEXTROMETHORPHAN, GUAIFENESIN	RMT HEALTH LLC	4fe9ad93-cdc4-b4df-e063-6294a90a90ae	2026-05-15	Warnings	Exact identifier application number: M012 unii: 9D2RTI9KYH
CounterAct Cough Drops Orchard Cherry	MENTHOL	Melaleuca, Inc.	6049842c-d763-4a91-a225-976ed74e1693	2026-05-15	Warnings	Exact identifier application number: M012
CounterAct Cough Drops Honey Lemon	MENTHOL	Melaleuca, Inc.	84ac3489-9d64-401f-ab78-715af4de5440	2026-05-15	Warnings	Exact identifier application number: M012
ALKA SELTZER COLD Cold Flu and Congestion Maximum Strength Day Night Fast Gels	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE	Bayer HealthCare LLC.	51e03b5b-b05a-07c1-e063-6394a90ab201	2026-05-15	Warnings	Exact identifier application number: M012
Oxycodone and Acetaminophen	OXYCODONE AND ACETAMINOPHEN	St. Mary's Medical Park Pharmacy	3cf4c474-556e-5ebf-e063-6394a90acaf0	2026-05-15	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 362O9ITL9D
ACETAMINOPHEN AND CODEINE PHOSPHATE	ACETAMINOPHEN AND CODEINE PHOSPHATE	Bryant Ranch Prepack	ff77a959-c77a-4911-8f7c-e2a3e24a6305	2026-05-15	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 362O9ITL9D
Sinus Congestion and Pain Relief Non-Drowsy/Daytime	ACETAMINOPHEN, GUAIFENESIN AND PHENYLEPHRINE HCL	Rite Aid Corporation	38d73a1e-ac78-4f67-9291-bb48ab80306e	2026-05-15	Warnings	Exact identifier application number: M012 unii: 04JA59TNSJ unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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