Theraflu

Product NDC: 0067-7917
11-digit product format: 000677917
Labeler code: 0067
Product ID: 0067-7917_1006345e-67d7-8b81-e063-6294a90ad7cd
Type: HUMAN OTC DRUG
Nonproprietary name: ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE
Dosage form: POWDER, FOR SOLUTION
Route: ORAL
Labeler: Haleon US Holdings LLC
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2012-09-24
Substance: ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength: 650; 20; 10 mg/1; mg/1; mg/1
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: Daytime Severe Cold and Cough
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ACETAMINOPHEN	650 mg/1
DEXTROMETHORPHAN HYDROBROMIDE	20 mg/1
PHENYLEPHRINE HYDROCHLORIDE	10 mg/1

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
1659967	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
c0689223-5c90-4dbc-bbfa-f94e267504c3	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
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
42f3c020-f1b3-89bc-7bdc-e1f10e680485	Product name	1	20140508
76633df9-0d59-4b88-03ed-21dee1b966f8	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
0067-7917-06	TherafluDaytime Severe Cold and Cough	1 in 1 PACKET	POWDER, FOR SOLUTION	1		8
0067-7917-06	TherafluDaytime Severe Cold and Cough	6 in 1 CARTON	POWDER, FOR SOLUTION	6		8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0067-7917-06	EA - Each	0067-7917	a93e7ffe-37c0-43d7-b368-02efbb23b376	1	2016-12-07

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	THERAFLU DAYTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH]	1
DEXTROMETHORPHAN HYDROBROMIDE	ACTIVE INGREDIENT	9D2RTI9KYH	THERAFLU DAYTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH]	1
PHENYLEPHRINE HYDROCHLORIDE	ACTIVE INGREDIENT	04JA59TNSJ	THERAFLU DAYTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH]	1
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	THERAFLU DAYTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH]	1
DEXTROMETHORPHAN	ACTIVE MOIETY	7355X3ROTS	THERAFLU DAYTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH]	1
PHENYLEPHRINE	ACTIVE MOIETY	1WS297W6MV	THERAFLU DAYTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH]	1
ACESULFAME POTASSIUM	INACTIVE INGREDIENT	23OV73Q5G9	THERAFLU DAYTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH]	1
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	THERAFLU DAYTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH]	1
ASPARTAME	INACTIVE INGREDIENT	Z0H242BBR1	THERAFLU DAYTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	THERAFLU DAYTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	THERAFLU DAYTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	THERAFLU DAYTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH]	1
MALTODEXTRIN	INACTIVE INGREDIENT	7CVR7L4A2D	THERAFLU DAYTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	THERAFLU DAYTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH]	1
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	THERAFLU DAYTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH]	1
SUCROSE	INACTIVE INGREDIENT	C151H8M554	THERAFLU DAYTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH]	1
TRIBASIC CALCIUM PHOSPHATE	INACTIVE INGREDIENT	91D9GV0Z28	THERAFLU DAYTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0067-7917	THERAFLU DAYTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE) POWDER, FOR SOLUTION [HALEON US HOLDINGS LLC]	8	Current NDC, Legacy NDC, 2 package rows	20240129_c0689223-5c90-4dbc-bbfa-f94e267504c3.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 67 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sorbutuss NR	SORBUTUSS	Dextrum Laboratories Inc.	304f1d5a-218c-51ae-e054-00144ff88e88	2025-12-26	Warnings	Exact identifier application number: M012
caring mill Cough drops CHERRY	MENTHOL	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	274a28aa-00e9-8b9d-e063-6394a90ace2a	2025-12-26	Warnings	Exact identifier application number: M012
Creamy Strawberry Flavor Cough Drop	CREAMY STRAWBERRY FLAVOR COUGH DROP WITH MENTHOL AND PECTIN	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	2749b83a-ea4f-d8ca-e063-6394a90a69b7	2025-12-26	Warnings	Exact identifier application number: M012
DISCOUNT DRUG MART	COUGH DROPS CHERRY	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	29f4a026-c4d2-2645-e063-6294a90aac58	2025-12-26	Warnings	Exact identifier application number: M012
DISCOUNT DRUG MART	COUGH DROPS MENTHOL	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	274a13b5-6fcb-70ed-e063-6394a90a7fb3	2025-12-26	Warnings	Exact identifier application number: M012
Honey Lemon Flavor Cough Drop	HONEY LEMON FLAVOR COUGH DROP	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	274a4802-7c02-ccce-e063-6394a90ad71d	2025-12-26	Warnings	Exact identifier application number: M012
DISCOUNT DRUG MART	COUGH DROPS HONEY LEMON	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	2749f353-9286-15b9-e063-6394a90a7693	2025-12-26	Warnings	Exact identifier application number: M012
Leader Cough Drops Vanilla Honey	MENTHOL	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	26a93c2c-a663-e3d1-e063-6394a90ad859	2025-12-26	Warnings	Exact identifier application number: M012
Nite-Time COLD/FLU Medicine	ACETAMINOPHEN	AptaPharma Inc.	344440bc-d810-4296-93ec-e6ae6673856b	2025-12-26	Warnings	Exact identifier application number: M012
Nite-Time COLD/FLU Medicine Cherry	ACETAMINOPHEN	AptaPharma Inc.	87c2b823-ed88-44f3-8f6a-df30430b40f3	2025-12-26	Warnings	Exact identifier application number: M012
TUSSIN CF	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	AptaPharma Inc.	c005c6cf-7891-463e-b65d-1129ad4bf6ec	2025-12-26	Warnings	Exact identifier application number: M012
Childrens Allergy	DIPHENHYDRAMINE HYDROCHLORIDE	AptaPharma Inc.	b2cef61f-ab54-4a20-a7f7-6d3da4754e8b	2025-12-26	Warnings	Exact identifier application number: M012
CHILDRENS MUCUS RELIEF COUGH - CHERRY FLAVOR	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	AptaPharma Inc.	9ae6fe74-80cd-482a-b3b9-3acafd6708ec	2025-12-26	Warnings	Exact identifier application number: M012
Tussin Expectorant	GUAIFENESIN	AptaPharma, Inc.	ca8fa216-09c1-42b2-a95b-fa3d0f13363c	2025-12-26	Warnings	Exact identifier application number: M012
Gencare DayTime Cold and Flu Softgel	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Pioneer Life Sciences, LLC	a9875dc9-6a27-413c-a2c7-68a86483ffc1	2025-12-26	Warnings	Exact identifier application number: M012
MUCUS RELIEF	GUAIFENESIN 400 MG	Pioneer Life Sciences, LLC	3b7e0ee7-4dda-4bbe-842c-6cbbc208acd5	2025-12-26	Warnings	Exact identifier application number: M012
MUCUS RELIEF	GUAIFENESIN 400 MG	Pioneer Life Sciences, LLC	0d604fc6-7bb9-4f7c-99cd-fdae4df4bb6f	2025-12-26	Warnings	Exact identifier application number: M012
Mucus Relief DM	DEXTROMETHORPHAN HBR 20MG GUAIFENESIN 400MG	Pioneer Life Sciences, LLC	3ce0f096-906e-47eb-8061-0ac1e9d8ea55	2025-12-26	Warnings	Exact identifier application number: M012
MUCUS RELIEF	GUAIFENESIN 400 MG	Pioneer Life Sciences, LLC	1194c338-e115-4105-93d8-9ab833c43193	2025-12-26	Warnings	Exact identifier application number: M012
MUCUS RELIEF	GUAIFENESIN 400 MG	Pioneer Life Sciences, LLC	9c9e558d-d991-4a2e-aa13-37c0b08071e6	2025-12-26	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
1659967	acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG Granules for Oral Solution	PSN	c0689223-5c90-4dbc-bbfa-f94e267504c3	8
1659967	acetaminophen 650 MG / dextromethorphan hydrobromide 20 MG / phenylephrine hydrochloride 10 MG Granules for Oral Solution	SCD	c0689223-5c90-4dbc-bbfa-f94e267504c3	8
1659967	acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG Powder for Oral Solution	SY	c0689223-5c90-4dbc-bbfa-f94e267504c3	8
1659967	APAP 650 MG / Dextromethorphan Hydrobromide 20 MG / Phenylephrine Hydrochloride 10 MG Granules for Oral Solution	SY	c0689223-5c90-4dbc-bbfa-f94e267504c3	8
1659967	acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG Granules for Oral Solution	PSN	60acfcf4-5b55-40ef-b432-faeed8457881	1
1659967	acetaminophen 650 MG / dextromethorphan hydrobromide 20 MG / phenylephrine hydrochloride 10 MG Granules for Oral Solution	SCD	60acfcf4-5b55-40ef-b432-faeed8457881	1
1659967	acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG Powder for Oral Solution	SY	60acfcf4-5b55-40ef-b432-faeed8457881	1
1659967	APAP 650 MG / Dextromethorphan Hydrobromide 20 MG / Phenylephrine Hydrochloride 10 MG Granules for Oral Solution	SY	60acfcf4-5b55-40ef-b432-faeed8457881	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0067-7917-06	00067791706	6 PACKET in 1 CARTON (0067-7917-06) / 1 POWDER, FOR SOLUTION in 1 PACKET	6 packet	2012-09-24	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Drug Facts	Haleon US Holdings LLC	2024-01-28	HUMAN OTC DRUG LABEL	8
Theraflu Daytime Severe Cold and Cough	Select Corporation	2022-04-29	HUMAN OTC DRUG LABEL	1