Theraflu Severe Cold Relief Daytime Berry Burst

Product NDC: 0067-0106
11-digit product format: 000670106
Labeler code: 0067
Product ID: 0067-0106_132dee3d-4a55-2c83-e063-6294a90a6729
Type: HUMAN OTC DRUG
Nonproprietary name: ACETAMINOPHEN, DEXTROMETHORPHAN HBr
Dosage form: POWDER, FOR SOLUTION
Route: ORAL
Labeler: Haleon US Holdings LLC
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2023-12-01
Substance: ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE
Active strength: 650; 20 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 Severe Cold Relief Daytime Berry Burst
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ACETAMINOPHEN	650 mg/1
DEXTROMETHORPHAN HYDROBROMIDE	20 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
2670678	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
adf33520-4689-4de2-b9d8-c201518e9d26	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0067-0106-06	Theraflu Severe Cold Relief Daytime Berry Burst	6 in 1 CARTON	POWDER, FOR SOLUTION	6		2
0067-0106-06	Theraflu Severe Cold Relief Daytime Berry Burst	1 in 1 PACKET	POWDER, FOR SOLUTION	1		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0067-0106	THERAFLU SEVERE COLD RELIEF DAYTIME BERRY BURST (ACETAMINOPHEN, DEXTROMETHORPHAN HBR) POWDER, FOR SOLUTION [HALEON US HOLDINGS LLC]	2	Current NDC, 2 package rows	20240310_adf33520-4689-4de2-b9d8-c201518e9d26.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 172 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tussin DM Cough and Chest Congestion	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	DeMoulas Market Basket	e92d2f64-9690-42d3-b787-cafade3a8999	2023-12-29	Warnings	Exact identifier application number: M012
Cold and Sinus Maxium Strength	ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	DeMoulas Market Basket	6e5ca8e1-5a03-4e77-b385-d44387fb3bfc	2023-12-29	Warnings	Exact identifier application number: M012
Cold, Flu and Sore Throat Maxium Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	DeMoulas Market Basket	d98029c0-ccd9-47e1-996f-c7786cd4ecca	2023-12-29	Warnings	Exact identifier application number: M012
MAXIMUM STRENGTH Sinus Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE	Topco Associates LLC	0f2be061-bd0a-4e62-b994-6d0768ea647a	2023-12-29	Warnings	Exact identifier application number: M012
Tussin CF Multi-Symptom Cold	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	DeMoulas Market Basket	c19b9997-4037-48f3-b905-86da421a292d	2023-12-29	Warnings	Exact identifier application number: M012
HempNesic	MENTHOL, CAMPHOR	Blaine Labs Inc.	0239ada0-644d-4ef4-a3b8-df70246a3bc2	2023-12-21	Warnings	Exact identifier application number: M012
HempNesic	MENTHOL, CAMPHOR	Blaine Labs Inc.	a698502d-c1c5-41ca-8142-74338b834c8b	2023-12-21	Warnings	Exact identifier application number: M012
Father Johns Cough Medicine Plus	NASAL DECONGESTANT	Oakhurst Company	8b8aab0f-251b-6bd8-e053-2995a90ad748	2023-12-18	Warnings	Exact identifier application number: M012
Father Johns Medicine	DEXTROMETHORPHAN HBR	Oakhurst Company	8b8a249d-55af-cc98-e053-2995a90a431d	2023-12-18	Warnings	Exact identifier application number: M012
Daytime Sinus Severe	ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL TABLET, FILM-COATED	Lil' Drug Store Products, Inc.	e79d92d2-d73c-d44f-e053-2995a90a03d9	2023-12-15	Warnings	Exact identifier application number: M012
Allergy	DIPHENHYDRAMINE HCL TABLET	Lil' Drug Store Products, Inc.	e5339c39-1d66-b283-e053-2995a90a4317	2023-12-15	Warnings	Exact identifier application number: M012
Father Johns Medicine	DEXTROMETHORPHAN HBR	Humco Holding Group, Inc	a7b0669f-8da1-5a44-e053-2995a90a84d9	2023-12-15	Warnings	Exact identifier application number: M012
Ephedrine Hydrochloride	EPHEDRINE HYDROCHLORIDE	Walgreen Company	bcb81dc1-d854-30c0-e053-2a95a90a9fc7	2023-12-14	Warnings	Exact identifier application number: M012
Allergy, Circle K	DIPHENHYDRAMINE HCL 25MG TABLET	Lil' Drug Store Products, Inc.	d1f370ac-e7f4-baf7-e053-2995a90a1e50	2023-12-14	Warnings	Exact identifier application number: M012
Circle K Allergy Antihistamine	DIPHENHYDRAMINE HYDROCHLORIDE	Lil' Drug Store Products, Inc.	a6a1e3d9-575c-4adf-beb6-c9719de55c67	2023-12-14	Warnings	Exact identifier application number: M012
Non-Drowsy Sinus Severe, Circle K	ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL CAPLET, FILM-COATED	Lil' Drug Store products, Inc.	e78c456f-f62e-596d-e053-2995a90a2397	2023-12-14	Warnings	Exact identifier application number: M012
Non-Drowsy Max Cold	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCI TABLET, FILM-COATED	Lil' Drug Store Products, Inc.	e79f1a92-d8ea-e3f9-e053-2a95a90a2d37	2023-12-14	Warnings	Exact identifier application number: M012
Major Nasal Decongestant	OXYMETAZOLINE HYDROCHLORIDE	Major Pharmaceuticals	bcc1a001-4176-485d-aaf0-2037ca65c6b8	2023-12-14	Warnings	Exact identifier application number: M012
Major Nasal Decongestant	OXYMETAZOLINE HYDROCHLORIDE	Major Pharmaceuticals	edb49b17-06a7-4c25-bc7c-d62c1deac7f1	2023-12-13	Warnings	Exact identifier application number: M012
Family Wellness Oxymetazoline No Drip	OXYMETAZOLINE	FAMILY DOLLAR (Family Wellness)	0c006b1c-8ab2-4b9c-8738-e7001c1bb47d	2023-12-11	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
2670678	acetaminophen 650 MG / dextromethorphan HBr 20 MG Powder for Oral Solution	PSN	adf33520-4689-4de2-b9d8-c201518e9d26	2
2670678	acetaminophen 650 MG / dextromethorphan hydrobromide 20 MG Powder for Oral Solution	SCD	adf33520-4689-4de2-b9d8-c201518e9d26	2
2670678	acetaminophen 650 MG / dextromethorphan HBr 20 MG Granules for Oral Solution	SY	adf33520-4689-4de2-b9d8-c201518e9d26	2
2670678	acetaminophen 650 MG / dextromethorphan HBr 20 MG Packet for Oral Solution	SY	adf33520-4689-4de2-b9d8-c201518e9d26	2
2670678	APAP 650 MG / dextromethorphan hydrobromide 20 MG Powder for Oral Solution	SY	adf33520-4689-4de2-b9d8-c201518e9d26	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
0067-0106-06	00067010606	6 PACKET in 1 CARTON (0067-0106-06) / 1 POWDER, FOR SOLUTION in 1 PACKET	6 packet	2023-12-01	No	No	Current