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 11 of 366 · 7,315 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
nighttime severe cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Amazon.com Services LLC	2517b241-c433-440f-999d-5a32d5bbaa26	2026-08-19	Warnings	Exact identifier application number: M012 unii: 9D2RTI9KYH unii: 04JA59TNSJ unii: 362O9ITL9D
Phenylephrine Hydrochloride	PHENYLEPHRINE HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	e1a7ab4b-0afe-4463-a039-5be0323cf2f7	2026-08-19	Warnings, Adverse reactions	Exact identifier unii: 04JA59TNSJ
Daytime and Nighttime Cough and Chest Congestion Childrens	DEXTROMETHORPHAN HBR, GUAIFENESIN, CHLORPHENIRAMINE MALEATE	CVS Pharmacy	347f1731-5b85-4220-ae2b-9497a3afa4ed	2026-08-19	Warnings	Exact identifier application number: M012
Headache Relief Extra Strength	ACETAMINOPHEN, ASPIRIN, CAFFEINE	Safeway, Inc.	5e77dca4-2ff8-4a8c-94bd-f224b680ca23	2026-08-19	Warnings	Exact identifier unii: 362O9ITL9D
dg health pain relief pm extra strength	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	Dolgencorp Inc	4d1eddf0-eff7-4c47-b312-30dee08d9e5f	2026-08-19	Warnings	Exact identifier unii: TC2D6JAD40 unii: 362O9ITL9D
CareOne 8 Hour Pain Relief	ACETAMINOPHEN	American Sales Company	9b2b0ef0-7071-4536-8f74-8f1d6250e105	2026-08-19	Warnings	Exact identifier unii: 362O9ITL9D
CVS Maximum Strength Cold and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN ,PHENYLEPHRINE HCL	CVS PHARMACY	e1c246a4-7a8c-4761-ab26-13b5165029cc	2026-08-19	Warnings	Exact identifier application number: M012 unii: 9D2RTI9KYH unii: 04JA59TNSJ unii: 362O9ITL9D
CVS childrens Cough and Cold	CHLORPHENIRAMINE MALEATE, DEXTROMETRORPHAN HBR	CVS PHARMACY	035c5e2a-04e3-490b-8f1a-233a5cb6eadb	2026-08-19	Warnings	Exact identifier application number: M012 unii: 9D2RTI9KYH
CVS Nighttime Childrens Cold and Cough Multi-Symptom Relief	CHLORPHENIRAMINE MALEATE AND DEXTROMETHORPHAN HYDROBROMIDE	CVS PHARMACY	d66b1a2e-49b6-473b-acec-2694c73ce8b4	2026-08-19	Warnings	Exact identifier unii: 9D2RTI9KYH
rugby cough syrup	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Rugby Laboratories	89752c69-25c8-45e3-9021-f81b35b52d36	2026-08-19	Warnings	Exact identifier application number: M012 unii: 9D2RTI9KYH
CVS Maximum Strength	DEXTROMETHORPHAN HBR, GUAIFENESIN	CVS PHARMACY	3148f80f-8a0d-4b6c-85be-79085fc04444	2026-08-19	Warnings	Exact identifier application number: M012 unii: 9D2RTI9KYH
CVS Childrens Nighttime Multi Symptom Cold	ACETAMINOPHEN , DIPHENHYDRAMINE HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE	CVS PHARMACY	9b244ac8-4ca7-43a0-b328-88f15f0fcc9d	2026-08-19	Warnings	Exact identifier unii: 04JA59TNSJ unii: TC2D6JAD40 unii: 362O9ITL9D
Childrens Allergy Relief	DIPHENHYDRAMINE HCL	Rite Aid Corporation	aa7164a7-f842-457d-abee-0740bb8c1c90	2026-08-19	Warnings	Exact identifier application number: M012 unii: TC2D6JAD40
CVS	CHILDRENS STUFFY NOSE AND COLD	CVS PHARMACY, INC	6cff265d-94a3-4617-a366-fe970d97f05a	2026-08-19	Warnings	Exact identifier application number: M012 unii: 04JA59TNSJ
CVS Severe Congestion and Pain Relief	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	CVS	5a8e4320-bae1-4831-b66b-9babfe8888d6	2026-08-19	Warnings	Exact identifier application number: M012 unii: 04JA59TNSJ unii: 362O9ITL9D
CVS Mucus Relief DM Maximum Strength	DEXTROMETHORPHAN HBR AND GUAIFENESIN	CVS PHARMACY	0ae0c244-e019-4b35-890c-8e15e3d3f7ce	2026-08-19	Warnings	Exact identifier application number: M012 unii: 9D2RTI9KYH
CVS Severe Tussin CF Max	ACETAMINOPHEN, DEXTROMETHORPHAN HBR	CVS PHARMACY	e32881f5-2bb5-4756-aa86-a09473ab590b	2026-08-19	Warnings	Exact identifier application number: M012 unii: 9D2RTI9KYH unii: 362O9ITL9D
CVS Health Nighttime Sleep-Aid	DIPHENHYDRAMINE HYDROCHLORIDE	CVS Pharmacy,Inc.	a575a914-14a0-442c-a504-ac7a0aa0ac77	2026-08-18	Warnings	Exact identifier unii: TC2D6JAD40
CVS Health Nighttime Sleep-Aid	DIPHENHYDRAMINE HYDROCHLORIDE	CVS Pharmacy,Inc.	e8785ba8-e53e-491e-bbfe-04e860f36131	2026-08-18	Warnings	Exact identifier unii: TC2D6JAD40
Good Sense Tussin DM Max	DEXTROMETHORPHAN HBR, GUAIFENESIN	L. Perrigo Company	d2541ef0-a73c-43aa-91ff-fdbce2748c4f	2026-08-18	Warnings	Exact identifier application number: M012 unii: 9D2RTI9KYH

Reported adverse events (FAERS/openFDA)#

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