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 136 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
NICE Honey Lemon Cough Drops	MENTHOL	Leosons Overseas Corp	96da2c9d-2d0d-6252-e053-2995a90ac338	2024-11-19	Warnings	Exact identifier application number: M012
SanaTos Boost	DEXTROMETHORPHAN HBR	Pharmadel LLC	ae6a424f-f3f0-3f6c-e053-2995a90a972d	2024-11-18	Warnings	Exact identifier application number: M012
SanaTos Turbo Max Strength	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Pharmadel LLC	d56a071c-a747-5397-e053-2995a90aad8b	2024-11-18	Warnings	Exact identifier application number: M012
equaline childrens cold and cough	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	United Natural Foods, Inc. dba UNFI	a24021a0-ef68-4bce-ba53-d262d1025cc0	2024-11-17	Warnings	Exact identifier application number: M012
Cold and Cough DM	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Publix Super Markets Inc	4d5f93c1-7752-4948-ba58-c4385cfc24c8	2024-11-17	Warnings	Exact identifier application number: M012
Good Sense Childrens Cold and Cough	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	L. Perrigo Company	8a87104f-94a4-4585-afd5-d610eea32e39	2024-11-17	Warnings	Exact identifier application number: M012
equate childrens cold and cough	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Wal-Mart Stores Inc	c91e94f4-4c51-4fe7-ad2e-0b9dc58b51e4	2024-11-17	Warnings	Exact identifier application number: M012
foster and thrive childrens allergy relief	DIPHENHYDRAMINE HYDROCHLORIDE	Strategic Sourcing Services LLC	1eac715b-351c-4b47-8d1d-6e921813c1a4	2024-11-15	Warnings	Exact identifier application number: M012
basic care daytime severe cold and flu nighttime cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE	Amazon.com Services LLC	298d2796-5ae5-4346-b6d2-2ced2dd29dc3	2024-11-15	Warnings	Exact identifier application number: M012
dg health day time severe cold and flu relief night time severe cold and flu relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE	Dolgencorp, LLC	f721b393-9ad5-4fc6-a2c5-bd89e58caf16	2024-11-15	Warnings	Exact identifier application number: M012
basic care daytime severe cold and flu nighttime severe cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE	Amazon.com Services LLC	9f4daadb-fdaf-4ea9-bad9-7ed9f8cee7f2	2024-11-15	Warnings	Exact identifier application number: M012
Rompe Pecho EX	GUAIFENESIN	Efficient Laboratories Inc	89ea23a5-0da7-407e-83d9-77a0b562f3af	2024-11-14	Warnings	Exact identifier application number: M012
basic care daytime cold and flu nighttime cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Amazon.com Services LLC	ceb342da-ff6d-4c19-9f78-0033d028075e	2024-11-14	Warnings	Exact identifier application number: M012
Topcare Nite Time Day Time Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Topco Associates LLC	efb8e0e2-0795-4f4a-8ca6-955f33bee143	2024-11-14	Warnings	Exact identifier application number: M012
good neighbor pharmacy nasal four	PHENYLEPHRINE HYDROCHLORIDE	Amerisource Bergen	a3d637dc-d957-458c-8a75-f948601a31aa	2024-11-14	Warnings	Exact identifier application number: M012
nasal	OXYMETAZOLINE HYDROCHLORIDE	Meijer Distribution Inc	ec8db98f-4fd1-4644-b76f-ff04f72e87f4	2024-11-13	Warnings	Exact identifier application number: M012
dg health tussin	DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Dolgencorp, LLC	6f9b8267-1e0b-430b-8e44-06408ae82ea4	2024-11-13	Warnings	Exact identifier application number: M012
Walgreens Effervescent Cold Relief Plus	ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE	Walgreens	b60e2cf9-11ec-469e-e053-2a95a90a712a	2024-11-13	Warnings	Exact identifier application number: M012
Kroger Effervescent Cold Relief	ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE	Kroger Company	69333774-3cf4-384d-e053-2a91aa0a48b3	2024-11-13	Warnings	Exact identifier application number: M012
Effervescent Orange Cold Relief	ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE	H. E. Butt Grocery Company	6403fe3d-d82b-f4d5-e053-2991aa0ac7d6	2024-11-13	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