Theraflu Flu Relief Maximum Strength

Product NDC: 0067-8161
11-digit product format: 000678161
Labeler code: 0067
Product ID: 0067-8161_132b9415-743c-c981-e063-6394a90ae3de
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen, Dextromethorphan HBr and Acetaminophen, Chlorpheniramine maleate, Dextromethorphan HBr
Dosage form: KIT
Labeler: Haleon US Holdings LLC
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2022-06-27
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 Flu Relief Maximum Strength
Brand name suffix: Daytime Nighttime Combo Pack
Listing expiration: 2026-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
247324	Internal RxNorm lookup
1098496	Internal RxNorm lookup
2604579	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
68d3e88a-d1be-410b-92a1-863903b3aa61	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
43a1ed49-eae2-4840-8075-cb4b33478540	Product name	1	20230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587	Product name	7	20210201
d17a97fa-387f-690e-d2be-0083ab044a03	Product name	3	20170725
0fdb98e2-b951-a1ce-5715-2b187ba500ef	Product name	4	20170718
c6fba691-a132-4ede-95c6-f8c6bd696636	Product name	1	20150902
c0200ab5-4954-454e-9676-30b741b245bd	Product name	1	20150730
76633df9-0d59-4b88-03ed-21dee1b966f8	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0067-8161-01	Theraflu Flu Relief Maximum StrengthDaytime Nighttime Combo Pack	1 in 1 CARTON	KIT	1		3
0067-8162-01	Theraflu Flu Relief Maximum StrengthDaytime Nighttime Combo Pack	20 in 1 BLISTER PACK	TABLET	20	15 mg	3
0067-8163-01	Theraflu Flu Relief Maximum StrengthDaytime Nighttime Combo Pack	20 in 1 BLISTER PACK	TABLET	20	500 mg	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0067-8161	THERAFLU FLU RELIEF MAXIMUM STRENGTH DAYTIME NIGHTTIME COMBO PACK (ACETAMINOPHEN, DEXTROMETHORPHAN HBR AND ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR) KIT [HALEON US HOLDINGS LLC]	3	Current NDC, Legacy NDC, 3 package rows	20240310_68d3e88a-d1be-410b-92a1-863903b3aa61.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 145 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CareOne Fast Acting Nasal	PHENYLEPHRINE HYDROCHLORIDE	American Sales Company	95b22dce-ef54-4ab5-9cc3-0e1cefa09ec5	2024-10-24	Warnings	Exact identifier application number: M012
DAYTIME COLD AND FLU MULTI-SYMPTOM RELIEF	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Chain Drug Consortium, LLC	8cb0d0c8-c565-4c5a-97c5-8250a67e23a8	2024-10-24	Warnings	Exact identifier application number: M012
equate nighttime cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Wal-Mart Stores Inc	0d07a534-c67f-4041-a07c-ed7f68dfc426	2024-10-23	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	Marc Glassman, Inc.	90977b39-8ced-46bf-9d06-15306bce9b35	2024-10-23	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	Marc Glassman, Inc.	5d29d3e3-3666-4a2f-835f-9e01bf8f5eeb	2024-10-23	Warnings	Exact identifier application number: M012
Sinus Severe	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	MARC GLASSMAN, INC.	e2325f33-e4e4-1269-e053-2995a90ab4ac	2024-10-23	Warnings	Exact identifier application number: M012
Sinus Pressure plus Pain PE	ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE	MARC GLASSMAN, INC.	a8240d98-f0b0-3ded-e053-2a95a90a5cf9	2024-10-23	Warnings	Exact identifier application number: M012
Sinus plus Headache	ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE	MARC GLASSMAN, INC.	a82401f5-65b1-11e9-e053-2a95a90a499e	2024-10-23	Warnings	Exact identifier application number: M012
Allergy Multi Symptom	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDE	MARC GLASSMAN, INC.	a823db21-4863-45a6-e053-2995a90ab8e6	2024-10-23	Warnings	Exact identifier application number: M012
Cold Max	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	MARC GLASSMAN, INC.	e2346d0c-75cf-974c-e053-2a95a90a2857	2024-10-23	Warnings	Exact identifier application number: M012
Cold Multi-Symptom Nighttime	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	Marc Glassman, Inc.	ce573785-f77d-4314-9b7a-ef3f1f4f34d8	2024-10-23	Warnings	Exact identifier application number: M012
Cold plus Flu Severe	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	MARC GLASSMAN, INC.	e41a3dcc-45b4-4093-e053-2995a90a3b14	2024-10-23	Warnings	Exact identifier application number: M012
Cold plus Head Congestion Severe	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	MARC GLASSMAN, INC.	e41a7cc5-bd0e-b92b-e053-2995a90af50a	2024-10-23	Warnings	Exact identifier application number: M012
Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Kroger Company	1cd26a6a-4b50-4610-9fc8-278545d77f18	2024-10-23	Warnings	Exact identifier application number: M012
Nighttime Cold and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	CVS Pharmacy	c5dd40e5-b4e2-4963-9a53-b71da1ed5510	2024-10-23	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	Harris Teeter	832eb36c-21c6-46d7-b1f8-ab8b6f1e501e	2024-10-22	Warnings	Exact identifier application number: M012
Sinus plus Headache	ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE	Harris Teeter	c9d82968-b2ec-2f4b-e053-2a95a90a7f0c	2024-10-22	Warnings	Exact identifier application number: M012
Cold Max	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	Harris Teeter	b9d9ab99-44b1-455f-a29a-95c193a4808e	2024-10-22	Warnings	Exact identifier application number: M012
Mucus Relief Sinus Severe Congestion and Pain	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	HARRIS TEETER	b96c376e-578f-1124-e053-2a95a90acbb4	2024-10-22	Warnings	Exact identifier application number: M012
Tukol Honey Daytime and Nighttime Value Pack	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATE	Genomma Lab USA	bccc11d2-d227-4cbb-b0fc-ac6abb6dce57	2024-10-22	Warnings	Exact identifier application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2604579	{1 (acetaminophen 500 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 15 MG Oral Tablet) / 1 (acetaminophen 500 MG / dextromethorphan hydrobromide 15 MG Oral Tablet) } Pack	GPCK	68d3e88a-d1be-410b-92a1-863903b3aa61	3
2604579	1 daytime (acetaminophen 500 MG / dextromethorphan HBr 15 MG Oral Tablet) / 1 nighttime (acetaminophen 500 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 15 MG Oral Tablet) Pack	PSN	68d3e88a-d1be-410b-92a1-863903b3aa61	3
1098496	acetaminophen 500 MG / chlorpheniramine maleate 2 MG / dextromethorphan HBr 15 MG Oral Tablet	PSN	68d3e88a-d1be-410b-92a1-863903b3aa61	3
247324	acetaminophen 500 MG /dextromethorphan HBr 15 MG Oral Tablet	PSN	68d3e88a-d1be-410b-92a1-863903b3aa61	3
1098496	acetaminophen 500 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 15 MG Oral Tablet	SCD	68d3e88a-d1be-410b-92a1-863903b3aa61	3
247324	acetaminophen 500 MG / dextromethorphan hydrobromide 15 MG Oral Tablet	SCD	68d3e88a-d1be-410b-92a1-863903b3aa61	3
2604579	1 nighttime (acetaminophen 500 MG / chlorpheniramine maleate 2 MG / dextromethorphan HBr 15 MG Oral Tablet) / 1 daytime (acetaminophen 500 MG / dextromethorphan HBr 15 MG Oral Tablet) Pack	SY	68d3e88a-d1be-410b-92a1-863903b3aa61	3
247324	acetaminophen 500 MG /dextromethorphan HBr 15 MG Oral Tablet	SY	68d3e88a-d1be-410b-92a1-863903b3aa61	3
1098496	APAP 500 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 15 MG Oral Tablet	SY	68d3e88a-d1be-410b-92a1-863903b3aa61	3
247324	APAP 500 MG / Dextromethorphan Hydrobromide 15 MG Oral Tablet	SY	68d3e88a-d1be-410b-92a1-863903b3aa61	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0067-8161-01	00067816101	1 KIT in 1 CARTON (0067-8161-01) * 20 TABLET in 1 BLISTER PACK (0067-8162-01) * 20 TABLET in 1 BLISTER PACK (0067-8163-01)	1 kit	2022-06-27	0000-00-00	No	No	Current
0067-8162-01	00067816201	20 in 1 BLISTER PACK						Historical
0067-8163-01	00067816301	20 in 1 BLISTER PACK						Historical