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 53 of 359 · 7,167 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Oxycodone and Acetaminophen	OXYCODONE AND ACETAMINOPHEN	Bryant Ranch Prepack	4d9e7c39-3e71-48c7-87c7-302db1835f11	2026-05-15	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 362O9ITL9D
Oxycodone and Acetaminophen	OXYCODONE AND ACETAMINOPHEN	Bryant Ranch Prepack	e6c47385-638a-41cd-93d9-b7ee205aa094	2026-05-14	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 362O9ITL9D
Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR	WALMART INC.	071615ba-f50a-4d2a-a358-43140bccce72	2026-05-14	Warnings	Exact identifier application number: M012 unii: 9D2RTI9KYH unii: 362O9ITL9D
HEMORRHOIDAL WITH LIDOCAINE	GLYCERIN, LIDOCAINE, PHENYLEPHRINE HYDROCHLORIDE, WHITE PETROLATUM	CVS PHARMACY, INC	4d870c68-9e72-464e-b0b8-900d0d661e43	2026-05-14	Warnings	Exact identifier unii: 04JA59TNSJ
Severe Cold and Flu Nighttime Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	HyVee Inc	d4bcfabb-a054-4f53-8dc9-d361a03558b8	2026-05-14	Warnings	Exact identifier application number: M012
Cough and Chest Congestion DM Adult	DEXTROMETHORPHAN HBR, GUAIFENESIN	CVS Pharmacy	4444c05a-eba6-4633-b86f-34f455699fa9	2026-05-14	Warnings	Exact identifier application number: M012 unii: 9D2RTI9KYH
Topcare Day Time Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Topco Associates LLC	a88e5b8e-e6dd-4a1c-9628-5861d3205bdb	2026-05-14	Warnings	Exact identifier application number: M012 unii: 9D2RTI9KYH unii: 04JA59TNSJ unii: 362O9ITL9D
equate daytime cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Wal-Mart Stores Inc	69b24c67-cf4b-46d7-a44b-d1917cc876b1	2026-05-14	Warnings	Exact identifier application number: M012 unii: 9D2RTI9KYH unii: 04JA59TNSJ unii: 362O9ITL9D
Hydrocodone Bitartrate and Acetaminophen	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	Bryant Ranch Prepack	a8b9e9fe-e1a5-4a77-9a1f-d30eb622168c	2026-05-14	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 362O9ITL9D
Tramadol Hydrochloride and Acetaminophen	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	Bryant Ranch Prepack	ccf465b5-8ef8-4445-a0d4-23b5cf13188c	2026-05-14	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 362O9ITL9D
ACETAMINOPHEN AND CODEINE PHOSPHATE	ACETAMINOPHEN AND CODEINE PHOSPHATE	Bryant Ranch Prepack	f308fd07-f004-42de-963d-426b268bba93	2026-05-14	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 362O9ITL9D
Hydrocodone Bitartrate and Acetaminophen	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	Bryant Ranch Prepack	0cc8836b-f0af-42e0-bd77-53fd1dd1aca7	2026-05-13	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 362O9ITL9D
good sense migraine formula	ACETAMINOPHEN, ASPIRIN, CAFFEINE	L. Perrigo Company	f052512b-e55a-4369-8c9c-453c9a5686a3	2026-05-13	Warnings	Exact identifier unii: 362O9ITL9D
GILTUSS DIABETIC EX	GILTUSS DIABETIC EX	Gil Pharmaceutical Corp	ab7915e7-323a-4fe1-887a-a3bd3f0aac98	2026-05-13	Warnings	Exact identifier application number: M012
Giltuss EX Maximum Strength Expectorant	GILTUSS EX MAXIMUM STRENGTH EXPECTORANT	Gil Pharmaceutical Corp	950db1ca-6936-47f8-a112-e3594d4c922c	2026-05-13	Warnings	Exact identifier application number: M012
Giltuss EX Expectorant	GILTUSS EX EXPECTORANT	Gil Pharmaceutical Corp	3b363fb9-c4d3-446f-927c-f705ffc715b5	2026-05-13	Warnings	Exact identifier application number: M012
Giltuss HBP EX Expectorant	GILTUSS HBP EX EXPECTORANT	Gil Pharmaceutical Corp	31bd6356-27cf-4188-8fd5-9cd9392021ca	2026-05-13	Warnings	Exact identifier application number: M012
Halls Honey Lemon	MENTHOL	Mondelez Global LLC	aec46410-ffb1-4db4-b232-82110c562f69	2026-05-13	Warnings	Exact identifier application number: M012
Mucinex Fast-Max Chest Congestion Honey and Berry Flavor	GUAIFENESIN	Reckitt Benckiser LLC	8ec74cf2-88f5-40be-87e2-b756ab841754	2026-05-13	Warnings	Exact identifier application number: M012
Mucinex Fast-Max Cold and Flu	ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE	Reckitt Benckiser LLC	c16253d3-3824-458c-8840-e3a2fbe7682c	2026-05-13	Warnings	Exact identifier application number: M012 unii: 9D2RTI9KYH unii: 04JA59TNSJ unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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