Theraflu

Product NDC: 0067-0122
11-digit product format: 000670122
Labeler code: 0067
Product ID: 0067-0122_f147d82e-4429-4c7b-bd2b-e21a09f21c92
Type: HUMAN OTC DRUG
Nonproprietary name: acetaminophen, dextromethorphan hbr, diphenhydramine hcl
Dosage form: KIT
Labeler: Haleon US Holdings LLC
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2024-04-15
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Theraflu
Brand name suffix: Severe Cold Relief Combo Pack
Listing expiration: 2026-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 5 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2670598	Internal RxNorm lookup
2670677	Internal RxNorm lookup
2679420	Internal RxNorm lookup
2679425	Internal RxNorm lookup
2679426	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
f147d82e-4429-4c7b-bd2b-e21a09f21c92	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
0e2e0f88-b076-afe1-4bdd-32bca4375bec	Product name	3	20250127
3e48c9c4-918d-5d23-2f0b-d2398b06be54	Product name	1	20140508
865c72dd-0d94-daac-f728-ddd4ded2a79e	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0067-0100-06	TherafluSevere Cold Relief Combo Pack	1 in 1 PACKET	POWDER, FOR SOLUTION	1	500 mg	1
0067-0100-06	TherafluSevere Cold Relief Combo Pack	6 in 1 CARTON	POWDER, FOR SOLUTION		20 mg	1
0067-0101-06	TherafluSevere Cold Relief Combo Pack	1 in 1 PACKET	POWDER, FOR SOLUTION	1	25 mg	1
0067-0101-06	TherafluSevere Cold Relief Combo Pack	6 in 1 CARTON	POWDER, FOR SOLUTION		650 mg	1
0067-0122-01	TherafluSevere Cold Relief Combo Pack	1 in 1 PACKAGE, COMBINATION	KIT	1		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0067-0122	THERAFLU SEVERE COLD RELIEF COMBO PACK (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL) KIT [HALEON US HOLDINGS LLC]	1	Current NDC, 5 package rows	20240415_f147d82e-4429-4c7b-bd2b-e21a09f21c92.zip

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 169 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Allergy Sinus, Lil Drug Store	ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, CHLORPHENIRAMINE MALEATE	Lil' Drug Store Products, Inc.	1145440e-b37a-6e5e-e063-6294a90ab4a0	2024-02-13	Warnings	Exact identifier application number: M012
Guaifenesin and Codeine Phosphate	GUAIFENESIN AND CODEINE PHOSPHATE	A-S Medication Solutions	36140639-e7a8-43bc-83e2-469430af9d1a	2024-02-13	Warnings	Exact identifier application number: M012
Theraflu ExpressMax Daytime Severe Cold and Cough	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Haleon US Holdings LLC	ff48b55a-0d32-47d6-941d-d99c7cf52f94	2024-02-12	Warnings	Exact identifier application number: M012
Childrens Robitussin Cough and Chest Congestion DM	DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN	Haleon US Holdings LLC	15950273-14c9-4a0b-bbb4-683048add722	2024-02-08	Warnings	Exact identifier application number: M012
THERAFLU Severe Cold Relief Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Haleon US Holdings LLC	7d902237-a990-4c5e-875b-291e124e143b	2024-02-03	Warnings	Exact identifier application number: M012
Tussin Cough and Chest Congestion DM	DEXTROMETHORPHAN HBR, GUAIFENESIN	Best Choice (Valu Merchandisers Company)	0f2d371d-f890-41e5-ac11-db5559d32466	2024-02-02	Warnings	Exact identifier application number: M012
Theraflu Severe Cold Relief Nighttime	ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL	Haleon US Holdings LLC	4daca846-8511-4303-9e6c-9469f7f260ba	2024-02-02	Warnings	Exact identifier application number: M012
CVS Health COUGH SUPPRESSANT SOFTGEL	DEXTROMETHORPHAN HYDROBROMIDE	CVS Pharmacy, Inc.	f676dfeb-fba8-419d-8a47-c3880e4100cc	2024-02-02	Warnings	Exact identifier application number: M012
Nighttime Cold and Flu ReadyInCase	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	P & L Development, LLC	155a7168-b568-41f4-b8a2-214889b4eccf	2024-02-02	Warnings	Exact identifier application number: M012
Vaporizing Chest Rub Lavender 4oz	CAMPHOR/MENTHOL	Rejoice International Corp.	104e1a38-3472-b9e2-e063-6294a90a38cf	2024-02-01	Warnings	Exact identifier application number: M012
Vaporizing Chest Rub Lavender 4oz	CAMPHOR/MENTHOL	China Ningbo Shangge Cosmetics Technology Corp.	104f5b07-eed2-566c-e063-6294a90a6505	2024-02-01	Warnings	Exact identifier application number: M012
CHILDRENS COLD COUGH and SORE THROAT MIXED BERRY	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	AptaPharma Inc.	5962a73e-72e4-493b-94a7-43bc6cf9c82f	2024-02-01	Warnings	Exact identifier application number: M012
good sense allergy relief	DIPHENHYDRAMINE HYDROCHLORIDE	L. Perrigo Company	2cfa69b4-e33f-442a-a6df-b021b041da14	2024-02-01	Warnings	Exact identifier application number: M012
Theraflu Severe Cold Relief Daytime and Theraflu Severe Cold Relief Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, DIPHENHYDRAMINE HCL	Haleon US Holdings LLC	e5ef7b85-feee-44a7-bd0e-ed91352c7434	2024-01-31	Warnings	Exact identifier application number: M012
SEVERE CONGESTION and COUGH MAX	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	AptaPharma Inc.	17a07d2d-f2da-4e51-9a77-6f0c174987bb	2024-01-31	Warnings	Exact identifier application number: M012
Maximum strength Max Cold and Sinus	ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL	AptaPharma Inc.	263dae13-5f92-4505-8bcc-e903d05b9a0c	2024-01-31	Warnings	Exact identifier application number: M012
THERAFLU POWERPODS NIGHTTIME SEVERE COLD	ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL	Haleon US Holdings LLC	39f9feef-4bf2-4f10-9fff-22bbb1d8a471	2024-01-30	Warnings	Exact identifier application number: M012
Theraflu Daytime Severe Cold and Cough	ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE	Haleon US Holdings LLC	c0689223-5c90-4dbc-bbfa-f94e267504c3	2024-01-28	Warnings	Exact identifier application number: M012
THERAFLU MULTI-SYMPTOM SEVERE COLD	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Haleon US Holdings LLC	a4c56ca0-7785-404b-996d-137cc135f270	2024-01-28	Warnings	Exact identifier application number: M012
THERAFLU NIGHTTIME SEVERE COLD AND COUGH	ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL	Haleon US Holdings LLC	5f7f6f70-0f36-4541-89f2-d953259cdb1e	2024-01-28	Warnings	Exact identifier application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2679426	{1 (acetaminophen 500 MG / dextromethorphan hydrobromide 20 MG Granules for Oral Solution) / 1 (acetaminophen 650 MG / diphenhydramine hydrochloride 25 MG Granules for Oral Solution) } Pack	GPCK	f147d82e-4429-4c7b-bd2b-e21a09f21c92	1
2679426	1 daytime (acetaminophen 500 MG / dextromethorphan HBr 20 MG Granules for Oral Solution) / 1 nighttime (acetaminophen 650 MG / diphenhydrAMINE HCl 25 MG Granules for Oral Solution) Pack	PSN	f147d82e-4429-4c7b-bd2b-e21a09f21c92	1
2679420	acetaminophen 500 MG / dextromethorphan hydrobromide 20 MG Granules for Oral Solution	PSN	f147d82e-4429-4c7b-bd2b-e21a09f21c92	1
2670598	acetaminophen 500 MG / dextromethorphan hydrobromide 20 MG Powder for Oral Solution	PSN	f147d82e-4429-4c7b-bd2b-e21a09f21c92	1
2670677	acetaminophen 650 MG / diphenhydrAMINE HCl 25 MG Powder for Oral Solution	PSN	f147d82e-4429-4c7b-bd2b-e21a09f21c92	1
2679425	acetaminophen 650 MG / diphenhydrAMINE hydrochloride 25 MG Granules for Oral Solution	PSN	f147d82e-4429-4c7b-bd2b-e21a09f21c92	1
2679420	acetaminophen 500 MG / dextromethorphan hydrobromide 20 MG Granules for Oral Solution	SCD	f147d82e-4429-4c7b-bd2b-e21a09f21c92	1
2670598	acetaminophen 500 MG / dextromethorphan hydrobromide 20 MG Powder for Oral Solution	SCD	f147d82e-4429-4c7b-bd2b-e21a09f21c92	1
2679425	acetaminophen 650 MG / diphenhydramine hydrochloride 25 MG Granules for Oral Solution	SCD	f147d82e-4429-4c7b-bd2b-e21a09f21c92	1
2670677	acetaminophen 650 MG / diphenhydramine hydrochloride 25 MG Powder for Oral Solution	SCD	f147d82e-4429-4c7b-bd2b-e21a09f21c92	1
2679426	{1 (acetaminophen 500 MG / dextromethorphan hydrobromide 20 MG Powder for Oral Solution) / 1 (acetaminophen 650 MG / diphenhydramine hydrochloride 25 MG Powder for Oral Solution) } Pack	SY	f147d82e-4429-4c7b-bd2b-e21a09f21c92	1
2679426	1 daytime (acetaminophen 500 MG / dextromethorphan HBr 20 MG Granules for Oral Solution) / 1 nighttime (acetaminophen 650 MG / diphenhydramine HCl 25 MG Granules for Oral Solution) Pack	SY	f147d82e-4429-4c7b-bd2b-e21a09f21c92	1
2670677	acetaminophen 650 MG / diphenhydramine HCl 25 MG Granules for Oral Solution	SY	f147d82e-4429-4c7b-bd2b-e21a09f21c92	1
2670677	acetaminophen 650 MG / diphenhydramine HCl 25 MG Packet for Oral Solution	SY	f147d82e-4429-4c7b-bd2b-e21a09f21c92	1
2679420	APAP 500 MG / dextromethorphan hydrobromide 20 MG Granules for Oral Solution	SY	f147d82e-4429-4c7b-bd2b-e21a09f21c92	1
2670598	APAP 500 MG / dextromethorphan hydrobromide 20 MG Powder for Oral Solution	SY	f147d82e-4429-4c7b-bd2b-e21a09f21c92	1
2679425	APAP 650 MG / diphenhydramine hydrochloride 25 MG Granules for Oral Solution	SY	f147d82e-4429-4c7b-bd2b-e21a09f21c92	1
2670677	APAP 650 MG / diphenhydramine hydrochloride 25 MG Powder for Oral Solution	SY	f147d82e-4429-4c7b-bd2b-e21a09f21c92	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
0067-0100-06	00067010006	1 in 1 PACKET					Historical
0067-0101-06	00067010106	1 in 1 PACKET					Historical
0067-0122-01	00067012201	1 KIT in 1 PACKAGE, COMBINATION (0067-0122-01) * 6 PACKET in 1 CARTON (0067-0100-06) / 1 POWDER, FOR SOLUTION in 1 PACKET * 6 PACKET in 1 CARTON (0067-0101-06) / 1 POWDER, FOR SOLUTION in 1 PACKET	1 kit	2024-04-15	No	No	Current