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 93 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
VANACOF DM	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	GM Pharmaceuticals, INC	2ed699f2-d004-4fa9-8042-6c85a9ff69b6	2025-11-03	Warnings	Exact identifier application number: M012
Geri Dryl	DIPHENHYDRAMINE HCL	VERITYRX, LLC	42a05f69-0599-5571-e063-6394a90a37d3	2025-11-02	Warnings	Exact identifier application number: M012
M-Dryl	DIPHENHYDRAMINE HYDROCHLORIDE	VERITYRX, LLC	42a0e577-a1b6-2c16-e063-6294a90af8e3	2025-11-02	Warnings	Exact identifier application number: M012
Severe Sinus Congestion and Pain	ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE	Shield Pharmaceuticals Corp	c296efd0-5030-4a26-a9b0-e66423d995dc	2025-10-31	Warnings	Exact identifier application number: M012
Daytime Cold and Flu Max Maximum Strength Softgels	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Topco Associates, LLC	f7ebe482-cb22-4517-8463-3432cf60071d	2025-10-31	Warnings	Exact identifier application number: M012
Nighttime Cold and Flu Max Softgels	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Topco Associates, LLC	787bff76-0ee2-4e7e-b908-876e4a3e3bfc	2025-10-31	Warnings	Exact identifier application number: M012
Honey Lemon Cough Drops	MENTHOL	Trader Joe's Company	647dadae-f37a-8399-e053-2991aa0aedb3	2025-10-31	Warnings	Exact identifier application number: M012
Family Care Saline	SODIUM CHLORIDE	United Exchange Corp.	06737393-d4ae-3e7b-e063-6394a90ac19f	2025-10-31	Warnings	Exact identifier application number: M012
QUALITY CHOICE Maximum Strength Daytime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Chain Drug Marketing Association, Inc.	40416ff5-06e1-97dd-e063-6394a90a2046	2025-10-30	Warnings	Exact identifier application number: M012
Robitussin Maximum Strength Nighttime Cough DM	DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Haleon US Holdings LLC	44feee2f-25bc-48d4-8e13-db1d9daaaa90	2025-10-30	Warnings	Exact identifier application number: M012
Robitussin Day and Night Cough Relief DM Max	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, DOXYLAMINE SUCCINATE	Haleon US Holdings LLC	b3d02c91-8f79-4eb4-a378-1072474c572c	2025-10-30	Warnings	Exact identifier application number: M012
ROBITUSSIN MAXIMUM STRENGTH COUGH PLUS CHEST CONGESTION DM	DEXTROMETHORPHAN HBR, GUAIFENESIN	Haleon US Holdings LLC	f1d022dd-c2ca-497f-87d5-9ef3e20e8ea7	2025-10-30	Warnings	Exact identifier application number: M012
Endal	TRIPROLIDINE HCL, DEXTROMETHORPHAN HBR	Poly Pharmaceuticals, Inc.	fc5401e2-ed65-72e7-e053-6294a90a81f3	2025-10-30	Warnings	Exact identifier application number: M012
daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Publix Super Markets Inc	c7cef266-46fc-49ab-a2e7-54fc56298659	2025-10-30	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	SAM'S WEST INC	16592ad7-b7cb-0837-e063-6394a90ae059	2025-10-29	Warnings	Exact identifier application number: M012
Maximum Strength Severe Congestion and Cough	DEXTROMETHORPHAN HBR, GUAIFENESIN, AND PHENYLEPHRINE HCL	SAFEWAY	013b94a1-26c7-4371-981a-d1b9d7fd1c98	2025-10-29	Warnings	Exact identifier application number: M012
Better Living	PHENYLEPHRINE HYDROCHLORIDE	BETTER LIVING BRANDS LLC	aea0db7f-e01a-4d8e-9c20-4a5ef4a905d1	2025-10-29	Warnings	Exact identifier application number: M012
AXIM DayTime - Night Time 72 Softgels	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	VIVUNT PHARMA LLC	de9eb2d5-ba51-4637-e053-2995a90a0451	2025-10-29	Warnings	Exact identifier application number: M012
Dollar General Vapor Steam	CAMPHOR (SYNTHETIC)	DOLGENCORP, LLC	86d0f3ac-1359-c2f9-e053-2a91aa0a35d0	2025-10-29	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	Strategic Sourcing Services LLC	5d628b09-c257-4369-8ddb-47554d83c0d8	2025-10-29	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