Theraflu

Product NDC: 0067-0123
11-digit product format: 000670123
Labeler code: 0067
Product ID: 0067-0123_682c5a4b-5ded-4276-903f-1ef1141ae518
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: 2024-06-01
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
682c5a4b-5ded-4276-903f-1ef1141ae518	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
bf324df6-7127-7deb-def5-2681c136cd03	Product name	3	20250325
0e2e0f88-b076-afe1-4bdd-32bca4375bec	Product name	3	20250127
43a1ed49-eae2-4840-8075-cb4b33478540	Product name	1	20230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587	Product name	7	20210201
3e48c9c4-918d-5d23-2f0b-d2398b06be54	Product name	1	20140508
76633df9-0d59-4b88-03ed-21dee1b966f8	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	6 in 1 CARTON	POWDER, FOR SOLUTION		500 mg	1
0067-0100-06	TherafluSevere Cold Relief Combo Pack	1 in 1 PACKET	POWDER, FOR SOLUTION	3	20 mg	1
0067-0101-06	TherafluSevere Cold Relief Combo Pack	6 in 1 CARTON	POWDER, FOR SOLUTION		650 mg	1
0067-0101-06	TherafluSevere Cold Relief Combo Pack	1 in 1 PACKET	POWDER, FOR SOLUTION	1	650 mg	1
0067-0123-01	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
0067-0123	THERAFLU SEVERE COLD RELIEF COMBO PACK (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL) KIT [HALEON US HOLDINGS LLC]	1	Current NDC, 5 package rows	20240704_682c5a4b-5ded-4276-903f-1ef1141ae518.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 5 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
MUCUS RELIEF	GUAIFENESIN	Geri-Care Pharmaceuticals, Corp	5afb242f-fac9-dc81-e063-6394a90a8448	2026-08-27	Warnings	Exact identifier application number: M012
daytime cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE	Amazon.com Services LLC	6de619d3-0ab0-43e7-8dac-7bbd5368ac65	2026-08-27	Warnings	Exact identifier application number: M012
Daytime Mucus Relief Severe Congestion and Cough and Nighttime Cold and Flu Maximum Strength	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI, ACETAMINOPHEN, DIPHENHYDRAMINE HCI	Walgreens	366ddac8-9e8a-41bd-a7f7-48213485a5f8	2026-08-27	Warnings	Exact identifier application number: M012
Nighttime Cold and Flu Maximum Strength	ACETAMINOPHEN, DIPHENHYDRAMINE HCI, PHENYLEPHRINE HCI	Walgreens	37896933-3ed3-457f-8a32-ee0d784a19e8	2026-08-27	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	Amazon.com Services LLC	298e9164-e378-4b39-a944-bfc8f8baa4de	2026-08-27	Warnings	Exact identifier application number: M012
DayTime Mucus Relief Severe Cold and Nighttime Cold and Flu Maximum Strength	DAYTIME ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI, NIGHTTIME ACETAMINOPHEN, DIPHENHYDRAMINE HCI, PHENYLEPHRINE HCI	Walgreens	3b4b3b04-eff9-4e06-8b37-f6729671d07f	2026-08-27	Warnings	Exact identifier application number: M012
Daytime Cold and Flu mini Softgels	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Shield Pharmaceuticals Corp	dfb0fe2e-b0c7-409a-bd1a-fd12485665ba	2026-08-26	Warnings	Exact identifier application number: M012
Nighttime Severe Cold and Flu Maximum Strength mini softgels	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Shield Pharmaceuticals Corp	70c5517d-be4e-4317-b4f4-df660c71c699	2026-08-26	Warnings	Exact identifier application number: M012
Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Meijer Distribution, Inc.	c1f9ec75-7eb2-405c-8cdc-097cbf2cf87d	2026-08-26	Warnings	Exact identifier application number: M012
Childrens TYLENOL COLD plus COUGH plus RUNNY NOSE	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND DEXTROMETHORPHAN HYDROBROMIDE	Kenvue Brands LLC	5b95905e-b729-4caf-921a-fc4ef815289c	2026-08-25	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	Wal-Mart Stores Inc	c88e93d4-66b6-4327-b9e5-0e0a95a18d66	2026-08-25	Warnings	Exact identifier application number: M012
Sleep Aid NightTime	DIPHENHYDRAMINE HCL	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	4fff664b-4ff0-4007-95ab-cb273807b9b4	2026-08-25	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	Walgreen Company	7d972559-6184-476b-9cbf-1bc5663ea00d	2026-08-24	Warnings	Exact identifier application number: M012
Cold, Flu and Sore Throat	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Meijer Distribution, Inc.	9be8437c-6053-4ed4-bdd2-97f556b5289e	2026-08-24	Warnings	Exact identifier application number: M012
Extra Strength Tylenol Cold Plus Flu Multi-Symptom Day Night	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, CHLORPHENIRAMINE MALEATE	Kenvue Brands LLC	594f515c-b369-816d-e063-6294a90a59a1	2026-08-21	Warnings	Exact identifier application number: M012
DG HEALTH MULTI SYMPTOM SEVERE COLD	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Dolgencorp, LLC	47ddbb0d-0823-4817-9c56-e7fff77d601c	2026-08-21	Warnings	Exact identifier application number: M012
Mucus Relief DM Max	DEXTROMETHORPHAN HBR, GUAIFENESIN	DOLGENCORP, LLC	5be4e730-3cd6-414e-a23b-f6cad8088750	2026-08-21	Warnings	Exact identifier application number: M012
Mucus Relief DM Cough Maximum Strength	DEXTROMETHORPHAN HBR AND GUAIFENESIN	Cardinal Health 110, LLC. DBA Leader	6304a581-9238-4539-b157-293fc05c173e	2026-08-21	Warnings	Exact identifier application number: M012
COMBINATION PACK HyVee Daytime and Nighttime Severe Cold and Flu SOFTGEL - 24ct	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE	HyVee Inc	82ead335-d38e-40c3-8031-222bf985a302	2026-08-20	Warnings	Exact identifier application number: M012
HyVee Nighttime Severe Cold and Flu SOFTGEL	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	HyVee Inc	49818610-bf4a-fb86-e063-6294a90ae598	2026-08-20	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	682c5a4b-5ded-4276-903f-1ef1141ae518	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	682c5a4b-5ded-4276-903f-1ef1141ae518	1
2679420	acetaminophen 500 MG / dextromethorphan hydrobromide 20 MG Granules for Oral Solution	PSN	682c5a4b-5ded-4276-903f-1ef1141ae518	1
2670598	acetaminophen 500 MG / dextromethorphan hydrobromide 20 MG Powder for Oral Solution	PSN	682c5a4b-5ded-4276-903f-1ef1141ae518	1
2670677	acetaminophen 650 MG / diphenhydrAMINE HCl 25 MG Powder for Oral Solution	PSN	682c5a4b-5ded-4276-903f-1ef1141ae518	1
2679425	acetaminophen 650 MG / diphenhydrAMINE hydrochloride 25 MG Granules for Oral Solution	PSN	682c5a4b-5ded-4276-903f-1ef1141ae518	1
2679420	acetaminophen 500 MG / dextromethorphan hydrobromide 20 MG Granules for Oral Solution	SCD	682c5a4b-5ded-4276-903f-1ef1141ae518	1
2670598	acetaminophen 500 MG / dextromethorphan hydrobromide 20 MG Powder for Oral Solution	SCD	682c5a4b-5ded-4276-903f-1ef1141ae518	1
2679425	acetaminophen 650 MG / diphenhydramine hydrochloride 25 MG Granules for Oral Solution	SCD	682c5a4b-5ded-4276-903f-1ef1141ae518	1
2670677	acetaminophen 650 MG / diphenhydramine hydrochloride 25 MG Powder for Oral Solution	SCD	682c5a4b-5ded-4276-903f-1ef1141ae518	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	682c5a4b-5ded-4276-903f-1ef1141ae518	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	682c5a4b-5ded-4276-903f-1ef1141ae518	1
2670677	acetaminophen 650 MG / diphenhydramine HCl 25 MG Granules for Oral Solution	SY	682c5a4b-5ded-4276-903f-1ef1141ae518	1
2670677	acetaminophen 650 MG / diphenhydramine HCl 25 MG Packet for Oral Solution	SY	682c5a4b-5ded-4276-903f-1ef1141ae518	1
2679420	APAP 500 MG / dextromethorphan hydrobromide 20 MG Granules for Oral Solution	SY	682c5a4b-5ded-4276-903f-1ef1141ae518	1
2670598	APAP 500 MG / dextromethorphan hydrobromide 20 MG Powder for Oral Solution	SY	682c5a4b-5ded-4276-903f-1ef1141ae518	1
2679425	APAP 650 MG / diphenhydramine hydrochloride 25 MG Granules for Oral Solution	SY	682c5a4b-5ded-4276-903f-1ef1141ae518	1
2670677	APAP 650 MG / diphenhydramine hydrochloride 25 MG Powder for Oral Solution	SY	682c5a4b-5ded-4276-903f-1ef1141ae518	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	6 in 1 CARTON					Historical
0067-0101-06	00067010106	6 in 1 CARTON					Historical
0067-0123-01	00067012301	1 KIT in 1 PACKAGE, COMBINATION (0067-0123-01) * 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	2024-06-01	No	No	Current