Theraflu

Product NDC: 0067-0111
11-digit product format: 000670111
Labeler code: 0067
Product ID: 0067-0111_91dbb541-6a86-4803-a1fe-1bf61b457c34
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen, Dextromethorphan HBr
Dosage form: TABLET, CHEWABLE
Route: ORAL
Labeler: Haleon US Holdings LLC
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2024-06-19
Substance: ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE
Active strength: 325; 10 mg/1; mg/1
Pharmacologic classes: 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 Soft Chews
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ACETAMINOPHEN	325 mg/1
DEXTROMETHORPHAN HYDROBROMIDE	10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2685209	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
91dbb541-6a86-4803-a1fe-1bf61b457c34	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e0d2eb29-08bd-4bba-90d1-c91c68a38767	Product name	4	20250516
bf324df6-7127-7deb-def5-2681c136cd03	Product name	3	20250325
43a1ed49-eae2-4840-8075-cb4b33478540	Product name	1	20230425
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
ba088a92-ab5e-b2d4-e908-f5ea691b7587	Product name	7	20210201
e92765c1-be81-432a-b909-1b10777ec378	Product name	1	20190208
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
76633df9-0d59-4b88-03ed-21dee1b966f8	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0067-0111-01	TherafluSevere Cold Relief Soft Chews	20 in 1 BOTTLE	TABLET, CHEWABLE	20		1
0067-0111-02	TherafluSevere Cold Relief Soft Chews	10 in 1 BOTTLE	TABLET, CHEWABLE	10		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0067-0111	THERAFLU SEVERE COLD RELIEF SOFT CHEWS (ACETAMINOPHEN, DEXTROMETHORPHAN HBR) TABLET, CHEWABLE [HALEON US HOLDINGS LLC]	1	Current NDC, 2 package rows	20240619_91dbb541-6a86-4803-a1fe-1bf61b457c34.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 35 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Allergy Childrens Allergy	DIPHENHYDRAMINE HYDROCHLORIDE	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	047102c4-3d03-4b2d-961d-0ac75980147b	2026-05-06	Warnings	Exact identifier application number: M012
GOOD SENSE COMBO PACK DAYTIME AND NIGHTTIME	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	L. Perrigo Company	d25f2649-4f8a-4339-8443-faa0b98bdd70	2026-05-06	Warnings	Exact identifier application number: M012
Allergy Relief 4 Hour	CHLORPHENIRAMINE MALEATE	WinCo Foods, LLC	27e911e1-6d22-4a50-8413-1809c8973cbd	2026-05-06	Warnings	Exact identifier application number: M012
ALKA SELTZER COLD Cold Cough Maximum Strength Fast Gels	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Bayer HealthCare LLC.	51173330-d537-fb9c-e063-6394a90ae342	2026-05-05	Warnings	Exact identifier application number: M012
Equate daytime severe vaporice cold and flu nighttime severe vapor ice cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE	Wal-Mart Stores Inc	08e74a8d-8e8d-4cda-9adc-ea2ff4068353	2026-05-05	Warnings	Exact identifier application number: M012
GOODSENSE COMBO PACK DAYTIME AND NIGHTTIME	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCL	L. Perrigo Company	e42f9e0d-f990-4c33-af43-75acf5d77638	2026-05-05	Warnings	Exact identifier application number: M012
Rugby Mucus and Chest Congestion 541	GUAIFENESIN	Rugby Laboratories	76472912-b66f-4bb4-937a-4a589683a78c	2026-05-04	Warnings	Exact identifier application number: M012
Sinus Congestion and Pain Daytime Non-Drowsy	ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE	H E B	e9dd2d7b-0a19-4a42-b51e-b9914f02406e	2026-05-04	Warnings	Exact identifier application number: M012
Sanatos Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Pharmadel LLC	3dd3ed85-0c0a-8390-e063-6294a90a668e	2026-05-04	Warnings	Exact identifier application number: M012
Good Sense Daytime non drowsy cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	L. Perrigo Company	0122cd34-5817-4af5-a51a-8d176dee0a30	2026-05-04	Warnings	Exact identifier application number: M012
COLD AND FLU RELIEF	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Safeway	d810a6a9-6112-4e9d-a396-36084b7e110e	2026-05-04	Warnings	Exact identifier application number: M012
Benadryl Allergy Ultratab	DIPHENHYDRAMINE HYDROCHLORIDE	Savings Distributors LLC	8d59d121-62a8-c43b-e053-2a95a90a5847	2026-05-01	Warnings	Exact identifier application number: M012
Tylenol Cold Plus Flu Severe	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Savings Distributors LLC	8e87f8de-f83e-0f8d-e053-2a95a90a8d6a	2026-05-01	Warnings	Exact identifier application number: M012
Tylenol Sinus Severe	ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Savings Distributors LLC	8eecb3f0-eb5e-e847-e053-2995a90a86bd	2026-05-01	Warnings	Exact identifier application number: M012
Sinus Pressure and Congestion Relief PE Maximum Strength	PHENYLEPHRINE HCL	Rite Aid Corporation	fccea3c5-42af-4939-82bc-d9409b75f91f	2026-05-01	Warnings	Exact identifier application number: M012
Night Time Cold and Flu original	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Harris Teeter, LLC	cfaf4b3d-fab4-424d-adbe-aaedca58912d	2026-04-30	Warnings	Exact identifier application number: M012
Nighttime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Harris Teeter, LLC	21e7d323-5b78-43aa-b0fc-34c2a864ab9a	2026-04-30	Warnings	Exact identifier application number: M012
daytime severe cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	H E B	ec0b5f4b-b58c-445f-acf1-c7ce301bba64	2026-04-30	Warnings	Exact identifier application number: M012
Mucus Relief DM Max Maximum Strength	DEXTROMETHORPHAN HBR, GUAIFENESIN	Harris Teeter, LLC	098428ae-e87d-4c29-8f02-1590530da58e	2026-04-29	Warnings	Exact identifier application number: M012
Panadol Cold and Flu Day	ACETAMINOPHEN, DEXTROMETHORPHAN HBR	Haleon US Holdings LLC	341761b9-f0be-f816-e063-6394a90a5e63	2026-04-29	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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2685209	acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG Chewable Tablet	PSN	91dbb541-6a86-4803-a1fe-1bf61b457c34	1
2685209	acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG Chewable Tablet	SCD	91dbb541-6a86-4803-a1fe-1bf61b457c34	1
2685209	APAP 325 MG / dextromethorphan hydrobromide 10 MG Chewable Tablet	SY	91dbb541-6a86-4803-a1fe-1bf61b457c34	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
0067-0111-01	00067011101	20 TABLET, CHEWABLE in 1 BOTTLE (0067-0111-01)	2024-06-19	No	No	Current
0067-0111-02	00067011102	10 TABLET, CHEWABLE in 1 BOTTLE (0067-0111-02)	2024-06-19	No	No	Current