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 53 of 360 · 7,193 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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
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

Reported adverse events (FAERS/openFDA)#

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