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 31 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
MUCINEX Rapid Clear Day Night and Clear and Cool Nasal	ACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, TRIPROLIDINE HYDROCHLORIDE, AND OXYMETAZOLINE HYDROCHLORIDE	Reckitt Benckiser LLC	37dcb0ed-df56-1bec-e063-6394a90a695e	2026-05-13	Warnings	Exact identifier application number: M012
Mucinex Rapid Clear Pain, Headache, and Mucus Congestion and Sinus Max Clear and Cool	OXYMETAZOLINE HYDROCHLORIDE, ACETAMINOPHEN AND GUAIFENESIN	Reckitt Benckiser LLC	373e0d75-8def-4b98-e063-6394a90a5e47	2026-05-13	Warnings	Exact identifier application number: M012
MUCINEX SINUS-MAX SEVERE NASAL CONGESTION RELIEF CLEAR and COOL NASAL	OXYMETAZOLINE HYDROCHLORIDE	Reckitt Benckiser LLC	5a397466-8721-4060-a178-5ebfd7069cc9	2026-05-13	Warnings	Exact identifier application number: M012
Maximum Strength Mucinex Sinus-Max Pressure, Pain and Cough	ACETAMINOPHEN, GUAIFENESIN	Reckitt Benckiser LLC	350764de-7801-b24e-e063-6394a90ab3c3	2026-05-13	Warnings	Exact identifier application number: M012
Cepacol Extra Strength Sore Throat and Cough	BENZOCAINE AND DEXTROMETHORPHAN HYDROBROMIDE	Reckitt Benckiser LLC	c0cc32db-90f0-4106-8538-89821083ece1	2026-05-13	Warnings	Exact identifier application number: M012
Mucinex Cold and Flu	ACETAMINOPHEN, GUAIFENESIN	Reckitt Benckiser LLC	e8bc4131-f7b0-926a-e053-2995a90a40ac	2026-05-13	Warnings	Exact identifier application number: M012
Mucinex Cold, Flu, and Sore Throat	ACETAMINOPHEN, GUAIFENESIN	Reckitt Benckiser LLC	37ded76a-ee8d-f22c-e063-6394a90a00c2	2026-05-13	Warnings	Exact identifier application number: M012
Mucinex Night Time Severe Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE	Reckitt Benckiser LLC	fdb5c937-c148-eb46-e053-6394a90a8bed	2026-05-13	Warnings	Exact identifier application number: M012
Mucinex Cough Chest Congestion	DEXTROMETHORPHAN HBR, GUAIFENESIN	Reckitt Benckiser LLC	e9c32d81-cd9b-4ff2-e053-2995a90aa499	2026-05-13	Warnings	Exact identifier application number: M012
Mucinex Nightshift Cold and Flu Maximum Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND TRIPROLIDINE HYDROCHLORIDE	Reckitt Benckiser LLC	316b5569-b66f-f30c-e063-6394a90ae147	2026-05-13	Warnings	Exact identifier application number: M012
Mucinex Nightshift Cold and Flu Maximum Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND TRIPROLIDINE HYDROCHLORIDE	Reckitt Benckiser LLC	d9467ca2-df75-4fa1-92b3-d2101eb54a77	2026-05-13	Warnings	Exact identifier application number: M012
Mucinex Nightshift Severe Cold and Flu Maximum Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE	Reckitt Benckiser LLC	12420092-3ef6-464b-9106-2d56cd6ef200	2026-05-13	Warnings	Exact identifier application number: M012
Mucinex Nightshift Sinus Maximum Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE	Reckitt Benckiser LLC	09fdf96f-345f-43f2-9f0f-8303ac70849e	2026-05-13	Warnings	Exact identifier application number: M012
Mucinex Childrens Mighty Chews Night Time Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATE	Reckitt Benckiser LLC	2ce31244-9c6c-b7dd-e063-6394a90a31a8	2026-05-13	Warnings	Exact identifier application number: M012
equate daytime cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Wal-Mart Stores Inc	2ac53cc7-000f-41fd-b799-4e6d6886fe62	2026-05-13	Warnings	Exact identifier application number: M012
nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Publix Super Markets Inc	2201d5c0-bd51-47a7-9775-916b18573623	2026-05-13	Warnings	Exact identifier application number: M012
topcare nite time cold and flu relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Topco Associates LLC	f868e4a0-e9fb-4e6a-9984-29a218246241	2026-05-13	Warnings	Exact identifier application number: M012
nitetime cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Meijer Distribution Inc	582fa36b-6d0c-4ff3-80ab-6e0da4b209e4	2026-05-13	Warnings	Exact identifier application number: M012
SudoGest	PSEUDOEPHEDRINE HYDROCHLORIDE	Major Pharmaceuticals	78faa497-6743-b85b-e053-2a91aa0ae822	2026-05-12	Warnings	Exact identifier application number: M012
Allergy Relief mini Softgels	DIPHENHYDRAMINE HCI 25 MG	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	df1c620b-ff59-4126-99a5-1d6750888f2b	2026-05-12	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