Theraflu

Product NDC: 0067-0104
11-digit product format: 000670104
Labeler code: 0067
Product ID: 0067-0104_438018c4-8730-1a2d-e063-6294a90a4c46
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen, Dextromethorphan HBr, Guaifenesin
Dosage form: SYRUP
Route: ORAL
Labeler: Haleon US Holdings LLC
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2023-12-01
Substance: ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength: 650; 20; 400 mg/30mL; mg/30mL; mg/30mL
Pharmacologic classes: Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
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 Chest Congestion Daytime
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ACETAMINOPHEN	650 mg/30mL
DEXTROMETHORPHAN HYDROBROMIDE	20 mg/30mL
GUAIFENESIN	400 mg/30mL

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
495W7451VQ	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1042695	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
8c821671-dc68-4e27-aa87-b4e45ade9817	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
4fe95224-f543-4dbb-9445-8cca122b48c8	Product name	1	20150609
e8718272-64cb-4436-969b-176c3067c8f4	Product name	1	20150609
106ff02a-57e1-4c4c-a307-fd582ff4e311	Product name	1	20150212
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
0067-0104-08	TherafluSevere Cold Relief Chest Congestion Daytime	245.5 mL in 1 BOTTLE	SYRUP	245.5		5
0067-0104-08	TherafluSevere Cold Relief	245.5 mL in 1 BOTTLE	SYRUP	1 mL	650 mg in 30mL	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0067-0104	THERAFLU SEVERE COLD RELIEF CHEST CONGESTION DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN) SYRUP [HALEON US HOLDINGS LLC]	4	Current NDC, 1 package rows	20250116_8c821671-dc68-4e27-aa87-b4e45ade9817.zip
0067-0104	THERAFLU SEVERE COLD RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENPHYDRAMINE HCL, GUAIFENESIN) KIT [HALEON US HOLDINGS LLC]	1	Current NDC	20241016_b01cc9f5-53f2-40d8-acf1-6de180b3d0bf.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 125 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
OXYMETAZOLINE HYDROCHLORIDE	OXYMETAZOLINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION INC.	2ee2b332-9b85-45a6-b242-3f0ebfbd08a6	2024-12-26	Warnings	Exact identifier application number: M012
OXYMETAZOLINE HYDROCHLORIDE	OXYMETAZOLINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION INC	aebc7cf8-aaf7-4746-89f5-a64d0be1641e	2024-12-26	Warnings	Exact identifier application number: M012
Foster and Thrive Chest Congestion Relief	GUAIFENESIN	Strategic Sourcing Services LLC	a1661a66-5e8c-4144-9c82-cbbcc75fb222	2024-12-23	Warnings	Exact identifier application number: M012
Geri Dryl	DIPHENHYDRAMINE HCL	GERI-CARE PHARMACEUTICALS, CORP	34d36146-6827-4800-8483-c0edb8f4cc28	2024-12-23	Warnings	Exact identifier application number: M012
Guaiasorb DM	DEXTROMETHORPHAN HBR, GUAIFENESIN	Geri-Care Pharmaceuticals, Corp	6299e352-116e-43f2-b40f-c704a7bd5d61	2024-12-23	Warnings	Exact identifier application number: M012
Equaline Chest Congestion Relief	GUAIFENESIN	United Natural Foods, Inc. dba UNFI	ad9fde8b-10cd-4778-917d-1ed6b67e5ab1	2024-12-23	Warnings	Exact identifier application number: M012
Equaline Chest Congestion Relief DM DM	DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN	United Natural Foods, Inc. dba UNFI	a40f5893-eb96-4e0e-b965-d78293c48dc9	2024-12-23	Warnings	Exact identifier application number: M012
Tukol X-Pecto Miel Multi Symptom Cold	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Genomma Lab USA, Inc.	b9d32964-5bd7-44b0-be98-827d5310ed4f	2024-12-20	Warnings	Exact identifier application number: M012
Halls Honey Vanilla	MENTHOL	Mondelez Global LLC	8e94a1b8-8915-4595-b097-8a0a319d54aa	2024-12-20	Warnings	Exact identifier application number: M012
Halls Sugar Free Mentho-Lyptus	MENTHOL	Mondelez Global LLC	96046858-c57b-426e-8279-91b35e05bcdb	2024-12-20	Warnings	Exact identifier application number: M012
Vapor Inhaler levmetamfetamine nasal decongestant, Best Choice	LEVMETAMFETAMINE	Valu Merchandisers Company	3f1c086c-bc22-4abb-9921-565a13f30c20	2024-12-20	Warnings	Exact identifier application number: M012
Vapor Inhaler	LEVMETAMFETAMINE NASAL DECONGESTANT	Walgreens	77924474-ccc7-497b-9168-91490bcfadfc	2024-12-20	Warnings	Exact identifier application number: M012
Levmetamfetamine	LEVMETAMFETAMINE	Meijer, Inc.	d11e916f-90a6-4099-bf83-75f2dfbd6266	2024-12-20	Warnings	Exact identifier application number: M012
Vapor Inhaler levmetamfetamine nasal decongestant, DG health	LEVMETAMFETAMINE	Dolgencorp Inc.	5dbc5a2d-feae-40d8-a8d4-1d6155a1bbd3	2024-12-20	Warnings	Exact identifier application number: M012
Tukol Multi Symptom Cold	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Genomma Lab USA, Inc.	aef2ad43-145d-4abc-bccc-2c5fdd6882f9	2024-12-20	Warnings	Exact identifier application number: M012
Vapor Inhaler levmetamfetamine nasal decongestant, TopCare health	LEVMETAMFETAMINE	Topco Associates LLC	8f995561-759a-4837-a82a-640417a6f889	2024-12-20	Warnings	Exact identifier application number: M012
Childrens Cough	DEXTROMETHORPHAN HBR, GUAIFENESIN	Wal-Mart Stores, Inc.	50a0eaa5-fa73-4d84-86fc-3546c85cf353	2024-12-20	Warnings	Exact identifier application number: M012
Equate Childrens Multi symptom Cold Nighttime	ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL	Wal-Mart Stores, Inc.	bfdaec98-24fe-47e1-ad32-dc2ddc4ce8ee	2024-12-20	Warnings	Exact identifier application number: M012
Vapor Inhaler	LEVMETAMFETAMINE NASAL DECONGESTANT	C.D.M.A., Inc.	904b7e21-cce5-4b96-afc1-b36f532f98ac	2024-12-20	Warnings	Exact identifier application number: M012
Vapor Inhaler levmetamfetamine nasal decongestant, Equaline	LEVMETAMFETAMINE	Supervalu Inc.	44f72f34-d0b8-421f-b240-86286de874cf	2024-12-20	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
495W7451VQ	GUAIFENESIN	93-14-1	GUAIFENESIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1042695	acetaminophen 650 MG / dextromethorphan HBr 20 MG / guaiFENesin 400 MG in 30 mL Oral Solution	PSN	8c821671-dc68-4e27-aa87-b4e45ade9817	5
1042695	acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / guaifenesin 13.3 MG/ML Oral Solution	SCD	8c821671-dc68-4e27-aa87-b4e45ade9817	5
1042695	acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG in 15 mL Oral Solution	SY	8c821671-dc68-4e27-aa87-b4e45ade9817	5
1042695	acetaminophen 650 MG / dextromethorphan HBr 20 MG / guaiFENesin 400 MG in 30 mL Oral Solution	SY	8c821671-dc68-4e27-aa87-b4e45ade9817	5
1042695	APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 0.667 MG/ML / Guaifenesin 13.3 MG/ML Oral Solution	SY	8c821671-dc68-4e27-aa87-b4e45ade9817	5
2695452	{1 (acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / guaifenesin 13.3 MG/ML Oral Solution) / 1 (acetaminophen 21.7 MG/ML / diphenhydramine hydrochloride 0.833 MG/ML Oral Solution) } Pack	GPCK	b01cc9f5-53f2-40d8-acf1-6de180b3d0bf	1
2695452	1 daytime (acetaminophen 650 MG / dextromethorphan HBr 20 MG / guaiFENesin 400 in 30 mL Oral Solution) / 1 nighttime (acetaminophen 650 MG / diphenhydrAMINE HCl 25 MG in 30 mL Oral Solution) Pack	PSN	b01cc9f5-53f2-40d8-acf1-6de180b3d0bf	1
1042695	acetaminophen 650 MG / dextromethorphan HBr 20 MG / guaiFENesin 400 MG in 30 mL Oral Solution	PSN	b01cc9f5-53f2-40d8-acf1-6de180b3d0bf	1
1294607	acetaminophen 650 MG / diphenhydrAMINE HCl 25 MG in 30 mL Oral Solution	PSN	b01cc9f5-53f2-40d8-acf1-6de180b3d0bf	1
1042695	acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / guaifenesin 13.3 MG/ML Oral Solution	SCD	b01cc9f5-53f2-40d8-acf1-6de180b3d0bf	1
1294607	acetaminophen 21.7 MG/ML / diphenhydramine hydrochloride 0.833 MG/ML Oral Solution	SCD	b01cc9f5-53f2-40d8-acf1-6de180b3d0bf	1
2695452	1 daytime (acetaminophen 650 MG / dextromethorphan HBr 20 MG / guaiFENesin 400 per 30 mL Oral Solution) / 1 nighttime (acetaminophen 650 MG / diphenhydramine hydrochloride 25 MG per 30 mL Oral Solution) Pack	SY	b01cc9f5-53f2-40d8-acf1-6de180b3d0bf	1
1042695	acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG in 15 mL Oral Solution	SY	b01cc9f5-53f2-40d8-acf1-6de180b3d0bf	1
1042695	acetaminophen 650 MG / dextromethorphan HBr 20 MG / guaiFENesin 400 MG in 30 mL Oral Solution	SY	b01cc9f5-53f2-40d8-acf1-6de180b3d0bf	1
1042695	APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 0.667 MG/ML / Guaifenesin 13.3 MG/ML Oral Solution	SY	b01cc9f5-53f2-40d8-acf1-6de180b3d0bf	1
1294607	APAP 21.7 MG/ML / Diphenhydramine Hydrochloride 0.833 MG/ML Oral Solution	SY	b01cc9f5-53f2-40d8-acf1-6de180b3d0bf	1
1294607	APAP 325 MG / diphenhydramine hydrochloride 12.5 MG per 15 ML Oral Solution	SY	b01cc9f5-53f2-40d8-acf1-6de180b3d0bf	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
0067-0104-08	00067010408	245.5 mL in 1 BOTTLE (0067-0104-08)	245.5 ml	2023-12-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Drug Facts	Haleon US Holdings LLC	2025-11-13	HUMAN OTC DRUG LABEL	5
Drug Facts	Haleon US Holdings LLC	2024-10-14	HUMAN OTC DRUG LABEL	1