THERAFLU

Product NDC: 0067-6802
11-digit product format: 000676802
Labeler code: 0067
Product ID: 0067-6802_107bff13-9a2b-6c45-e063-6294a90a95a2
Type: HUMAN OTC DRUG
Nonproprietary name: ACETAMINOPHEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCl
Dosage form: POWDER, FOR SOLUTION
Route: ORAL
Labeler: Haleon US Holdings LLC
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2023-01-20
Substance: ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength: 500; 20; 10 mg/237mL; mg/237mL; mg/237mL
Pharmacologic classes: Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]
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 Daytime
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ACETAMINOPHEN	500 mg/237mL
DEXTROMETHORPHAN HYDROBROMIDE	20 mg/237mL
PHENYLEPHRINE HYDROCHLORIDE	10 mg/237mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
362O9ITL9D	Internal UNII lookup
9D2RTI9KYH	Internal UNII lookup
04JA59TNSJ	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1189316	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
7d902237-a990-4c5e-875b-291e124e143b	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e4e263da-1c53-440f-bb80-b7a575843b5a	Product name	1	20260313
d2168cac-a261-415a-9c78-3522859fa720	Product name	3	20251124
bf324df6-7127-7deb-def5-2681c136cd03	Product name	3	20250325
05a8cdd1-eeb8-409e-b938-0778225eca7d	Product name	4	20250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9	Product name	8	20250220
0e2e0f88-b076-afe1-4bdd-32bca4375bec	Product name	3	20250127
f489e8f3-5c9e-4818-b539-a73587edcfc7	Product name	2	20240229
0f7ae452-206d-4fc4-868d-56fc47074084	Product name	1	20231011
43a1ed49-eae2-4840-8075-cb4b33478540	Product name	1	20230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587	Product name	7	20210201
b5abe2e3-39a1-43eb-9bff-f3c1653fe3df	Product name	2	20190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814	Product name	3	20150910
3e48c9c4-918d-5d23-2f0b-d2398b06be54	Product name	1	20140508
42f3c020-f1b3-89bc-7bdc-e1f10e680485	Product name	1	20140508
76633df9-0d59-4b88-03ed-21dee1b966f8	Product name	1	20140508
865c72dd-0d94-daac-f728-ddd4ded2a79e	Product name	1	20140508
e949165d-714d-e548-2b76-0cb5def16f30	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0067-6802-02	Theraflu Severe Cold Relief Daytime and Theraflu Severe Cold Relief Nighttime	237 mL in 1 PACKET	POWDER, FOR SOLUTION	1422 mL	10 mg in 237mL	2
0067-6802-02	Theraflu Severe Cold Relief Daytime and Theraflu Severe Cold Relief Nighttime	6 in 1 CARTON	POWDER, FOR SOLUTION		20 mg in 237mL	2
0067-6802-02	THERAFLUSevere Cold Relief Daytime	6 in 1 CARTON	POWDER, FOR SOLUTION	6		1
0067-6802-02	THERAFLUSevere Cold Relief Daytime	237 mL in 1 PACKET	POWDER, FOR SOLUTION	237		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0067-6802	THERAFLU SEVERE COLD RELIEF DAYTIME AND THERAFLU SEVERE COLD RELIEF NIGHTTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, DIPHENHYDRAMINE HCL) KIT [HALEON US HOLDINGS LLC]	2	Current NDC	20240201_e5ef7b85-feee-44a7-bd0e-ed91352c7434.zip
0067-6802	THERAFLU SEVERE COLD RELIEF DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [HALEON US HOLDINGS LLC]	1	Current NDC, 2 package rows	20240204_7d902237-a990-4c5e-875b-291e124e143b.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 138 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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
Effervescent Cold Relief	ASPIRIN, CHLORPHENIRAMINE MALEATE, PHYLEPHRINE BITARTRATE	Topco Associates LLC	a2929bcb-fa81-4f15-b087-a9996b5e7d1f	2024-11-13	Warnings	Exact identifier application number: M012
Equate Effervescent Cold Relief	ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE	Walmart	6271bb48-74b2-eb57-e053-2991aa0afd1b	2024-11-13	Warnings	Exact identifier application number: M012
Equaline Effervescent Cold Relief	ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE	United Natural Foods, Inc. dba UNFI	6bf341e0-94b1-08ff-e053-2991aa0af634	2024-11-13	Warnings	Exact identifier application number: M012
Good Sense Effervescent Cold Relief	ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE	Good Sense	cd25e250-bb8b-7e83-e053-2a95a90a2639	2024-11-13	Warnings	Exact identifier application number: M012
Top Value Effervescent Cold Relief	ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE	Tower Laboratories Ltd	440a00b1-7960-0cc4-e054-00144ff8d46c	2024-11-13	Warnings	Exact identifier application number: M012
Top Value Effervescent Cold Relief - Orange	ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE	Tower Laboratories Ltd.	c6f207e8-bc0d-853a-e053-2a95a90ac623	2024-11-13	Warnings	Exact identifier application number: M012
Effervescent Orange Cold Relief	ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE	DOLGENCORP, LLC	7fad8e65-34fe-5313-e053-2a91aa0a56f4	2024-11-13	Warnings	Exact identifier application number: M012
Dollar General Effervescent Cold Relief	ASPIRIN, CHLORPHENIRAMINE MALEATE, PHYLEPHRINE BITARTRATE	DOLGENCORP, LLC	7face5c7-f5c7-7eee-e053-2991aa0ab064	2024-11-13	Warnings	Exact identifier application number: M012
Quality Choice Effervescent Cold Relief Plus	ASPIRIN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE BITARTRATE	Chain Drug Marketing Association	90622927-9682-4eb0-8c7f-894230b3dda4	2024-11-13	Warnings	Exact identifier application number: M012
Quality Choice Effervescent Cold Relief - Orange	ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE	Chain Drug Marketing Association	9f7d76f0-4f1c-a1c7-e053-2a95a90a3dca	2024-11-13	Warnings	Exact identifier application number: M012

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
362O9ITL9D	ACETAMINOPHEN	103-90-2	ACETAMINOPHEN
9D2RTI9KYH	DEXTROMETHORPHAN HYDROBROMIDE	6700-34-1	DEXTROMETHORPHAN HYDROBROMIDE
04JA59TNSJ	PHENYLEPHRINE HYDROCHLORIDE	61-76-7	PHENYLEPHRINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2640034	{1 (acetaminophen 500 MG / dextromethorphan hydrobromide 20 MG / phenylephrine hydrochloride 10 MG Granules for Oral Solution) / 1 (acetaminophen 650 MG / diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 10 MG Granules for Oral Solution) } Pack	GPCK	e5ef7b85-feee-44a7-bd0e-ed91352c7434	2
2640034	1 daytime (acetaminophen 500 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG Granules for Oral Solution) / 1 nighttime (acetaminophen 650 MG / diphenhydrAMINE HCl 25 MG / phenylephrine HCl 10 MG Granules for Oral Solution) Pack	PSN	e5ef7b85-feee-44a7-bd0e-ed91352c7434	2
1189316	acetaminophen 500 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG Granules for Oral Solution	PSN	e5ef7b85-feee-44a7-bd0e-ed91352c7434	2
1659960	acetaminophen 650 MG / diphenhydrAMINE HCl 25 MG / phenylephrine HCl 10 MG Granules for Oral Solution	PSN	e5ef7b85-feee-44a7-bd0e-ed91352c7434	2
1189316	acetaminophen 500 MG / dextromethorphan hydrobromide 20 MG / phenylephrine hydrochloride 10 MG Granules for Oral Solution	SCD	e5ef7b85-feee-44a7-bd0e-ed91352c7434	2
1659960	acetaminophen 650 MG / diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 10 MG Granules for Oral Solution	SCD	e5ef7b85-feee-44a7-bd0e-ed91352c7434	2
2640034	1 daytime (acetaminophen 500 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG Granules for Oral Solution) / 1 nighttime (acetaminophen 650 MG / diphenhydramine HCl 25 MG / phenylephrine HCl 10 MG Granules for Oral Solution) Pack	SY	e5ef7b85-feee-44a7-bd0e-ed91352c7434	2
1189316	acetaminophen 500 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG Packet for Oral Solution	SY	e5ef7b85-feee-44a7-bd0e-ed91352c7434	2
1189316	acetaminophen 500 MG / dextromethorphan hydrobromide 20 MG / phenylephrine hydrochloride 10 MG Powder for Oral Solution	SY	e5ef7b85-feee-44a7-bd0e-ed91352c7434	2
1659960	acetaminophen 650 MG / diphenhydramine HCl 25 MG / phenylephrine HCl 10 MG Packet for Oral Solution	SY	e5ef7b85-feee-44a7-bd0e-ed91352c7434	2
1659960	acetaminophen 650 MG / diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 10 MG Powder for Oral Solution	SY	e5ef7b85-feee-44a7-bd0e-ed91352c7434	2
1189316	APAP 500 MG / Dextromethorphan Hydrobromide 20 MG / Phenylephrine Hydrochloride 10 MG Granules for Oral Solution	SY	e5ef7b85-feee-44a7-bd0e-ed91352c7434	2
1659960	APAP 650 MG / Diphenhydramine Hydrochloride 25 MG / Phenylephrine Hydrochloride 10 MG Granules for Oral Solution	SY	e5ef7b85-feee-44a7-bd0e-ed91352c7434	2
1189316	acetaminophen 500 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG Granules for Oral Solution	PSN	7d902237-a990-4c5e-875b-291e124e143b	1
1189316	acetaminophen 500 MG / dextromethorphan hydrobromide 20 MG / phenylephrine hydrochloride 10 MG Granules for Oral Solution	SCD	7d902237-a990-4c5e-875b-291e124e143b	1
1189316	acetaminophen 500 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG Packet for Oral Solution	SY	7d902237-a990-4c5e-875b-291e124e143b	1
1189316	acetaminophen 500 MG / dextromethorphan hydrobromide 20 MG / phenylephrine hydrochloride 10 MG Powder for Oral Solution	SY	7d902237-a990-4c5e-875b-291e124e143b	1
1189316	APAP 500 MG / Dextromethorphan Hydrobromide 20 MG / Phenylephrine Hydrochloride 10 MG Granules for Oral Solution	SY	7d902237-a990-4c5e-875b-291e124e143b	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
0067-6802-02	00067680202	6 PACKET in 1 CARTON (0067-6802-02) / 237 mL in 1 PACKET	6 packet	2023-01-20	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Drug Facts	Haleon US Holdings LLC	2024-02-03	HUMAN OTC DRUG LABEL	1
Drug Facts	Haleon US Holdings LLC	2024-01-31	HUMAN OTC DRUG LABEL	2