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 25 of 362 · 7,224 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
infants fever reducer and pain reliever	ACETAMINOPHEN	Rite Aid Corporation	920e7055-7ed1-4db4-9215-f8933078bb7b	2026-07-24	Warnings	Exact identifier unii: 362O9ITL9D
Dye Free Pain and Fever Childrens	ACETAMINOPHEN	Walgreens	c6665c11-9a01-4472-a444-acadb1de0b69	2026-07-23	Warnings	Exact identifier unii: 362O9ITL9D
Wal Som Nighttime Sleep Aid	DIPHENHYDRAMINE HCL	Walgreens	ff475a69-dbb2-40a9-b7f4-9c7b7e975d19	2026-07-23	Warnings	Exact identifier unii: TC2D6JAD40
Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	Sportpharm LLC	e5af2dd2-cc91-46c7-bdb9-97a7cdddcb69	2026-07-23	Warnings, Adverse reactions	Exact identifier unii: TC2D6JAD40
DERMFREE HEMORRHOID	LIDOCAINE 4% PHENYLEPHRINE HCL 0.25% HEMORRHOID	Jiangxi Yudexi Pharmaceutical Co., LTD	4a5d0e79-d620-0147-e063-6294a90a3103	2026-07-23	Warnings	Exact identifier unii: 04JA59TNSJ
Giltuss Allergy Plus	CHLOPHEDIANOL HCL, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL	Gil Pharmaceutical Corp	85a0dc7f-ffb5-7d52-e053-2991aa0a602a	2026-07-23	Warnings	Exact identifier application number: M012 unii: 04JA59TNSJ
Giltuss Cough and Cold	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Gil Pharmaceutical Corp	8590fcc9-c0dd-f43b-e053-2991aa0a692e	2026-07-23	Warnings	Exact identifier application number: M012 unii: 9D2RTI9KYH unii: 04JA59TNSJ
Giltuss Sinus and Chest Congestion	GUAIFENESIN, PHENYLEPHRINE HCL	Gil Pharmaceutical Corp	8591003c-c2f2-df65-e053-2a91aa0a42fb	2026-07-23	Warnings	Exact identifier application number: M012 unii: 04JA59TNSJ
COLDTAC Plus	ACETAMINOPHEN, PHENYLEPHRIN HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE	OPMX LLC	3496866c-682f-420b-bfdb-64ecebbf70a2	2026-07-23	Warnings	Exact identifier application number: M012 unii: 9D2RTI9KYH unii: 04JA59TNSJ unii: 362O9ITL9D
Brompheniramine Maleate, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide	BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE	Sportpharm LLC	f3afca82-ba8f-4741-8332-b7939aa0ee5e	2026-07-23	Warnings, Adverse reactions	Exact identifier unii: 9D2RTI9KYH
nighttime cough dm	DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Meijer, Inc.	5a45b4c2-6a15-40b4-9ac6-d1554244ec42	2026-07-23	Warnings	Exact identifier application number: M012 unii: 9D2RTI9KYH
DAY TIME NITE TIME INTENSE FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Meijer, Inc.	6372cbdd-a3a3-499d-91ce-53bcdb83e739	2026-07-23	Warnings	Exact identifier application number: M012
Daytime Nighttime Cold Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	CVS Pharmacy	df6e522c-3e30-4aa0-8ab9-3b579c80bcad	2026-07-22	Warnings	Exact identifier application number: M012
Cold and Flu Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCL	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	0ab2ba6a-1fac-4a34-ab76-0b50b425d0ba	2026-07-22	Warnings	Exact identifier application number: M012 unii: 9D2RTI9KYH unii: 362O9ITL9D
TYLENOL COLD PLUS FLU MULTI-SYMPTOM GELS NIGHT	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND DOXYLAMINE SUCCINATE	Kenvue Brands LLC	1c5386c1-e45d-9dcb-e063-6294a90aff07	2026-07-22	Warnings	Exact identifier application number: M012 unii: 9D2RTI9KYH unii: 362O9ITL9D
Tylenol Extra Strength	ACETAMINOPHEN	Kenvue Brands LLC	103d109d-f520-409c-8da2-eb6b0fbec891	2026-07-22	Warnings	Exact identifier unii: 362O9ITL9D
Tylenol PM Extra Strength	ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE	Kenvue Brands LLC	ce58105b-f010-47af-8f31-6dd4ce4e9cba	2026-07-22	Warnings	Exact identifier unii: TC2D6JAD40 unii: 362O9ITL9D
Allergy plus Sinus Headache	ACETAMINOPHEN 325 MG, DIPHENHYDRAMINE HCL 12.5 MG, PHENYLEPHRINE HCL 5 MG	Shield Pharmaceuticals Corp	772d0184-8c41-40f1-bbef-7e68692eec66	2026-07-22	Warnings	Exact identifier application number: M012 unii: 04JA59TNSJ unii: TC2D6JAD40 unii: 362O9ITL9D
good sense allergy	DIPHENHYDRAMINE HCL	L. Perrigo Company	bf5039a0-2109-41a2-84a9-b5167d0a93da	2026-07-22	Warnings	Exact identifier application number: M012 unii: TC2D6JAD40
GOOD SENSE INFANTS PAIN AND FEVER	ACETAMINOPHEN	L. Perrigo Company	a7cc3964-e8fa-41da-89ca-b0d2aa80f2a7	2026-07-22	Warnings	Exact identifier unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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