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 84 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Afrin Original Pump Mist	OXYMETAZOLINE HYDROCHLORIDE	Bayer HealthCare LLC.	0f5ec576-f788-40aa-9088-0dd672e3cc7c	2025-12-04	Warnings	Exact identifier application number: M012
Adult Long Lasting Cough Relief	DEXTROMETHORPHAN HBR	Shield Pharmaceuticals Corp	432a79a9-c69d-4514-894a-7832e1b745ef	2025-12-04	Warnings	Exact identifier application number: M012
GENCONTUSS	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	KRAMER NOVIS	69d16d25-b09b-430e-8e01-0962d840dc21	2025-12-04	Warnings	Exact identifier application number: M012
Nasal Decongestant PE	PHENYLEPHRINE HCL	H E B	7c04ab14-af28-4598-90ef-56ac11902c7d	2025-12-04	Warnings	Exact identifier application number: M012
Desgen Pediatric	DEXTROMETHORPHAN HBR, GUIAFENESIN, PHENYLEPHRINE HCL	Kramer Novis	12425c1b-8bdc-446b-83dd-95e05a4d9b8c	2025-12-04	Warnings	Exact identifier application number: M012
Presgen B	DEXTROMETHORPHAN HYDROBROMIDE, BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE	KRAMER NOVIS	5befa829-32bd-4978-8a0e-1d6513ff37a4	2025-12-03	Warnings	Exact identifier application number: M012
TUSSLIN	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Kramer Novis	987e19a5-032f-44e9-b4c7-8a764d502695	2025-12-03	Warnings	Exact identifier application number: M012
DayTime Relief, Cold and Flu, 24-7 Life by 7-Eleven	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL SOLUTION	Lil' Drug Store Products, Inc.	450e8974-8ff8-4b82-e063-6394a90a9366	2025-12-03	Warnings	Exact identifier application number: M012
Nighttime Relief, Cold and Flu, 24-7 Life by 7-Eleven	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE SOLUTION	Lil' Drug Store Products, Inc.	4510223f-1c88-2796-e063-6394a90a18ac	2025-12-03	Warnings	Exact identifier application number: M012
Carolina Crud Crusher	DEXTROMETHORPHAN HBR, GUAIFENESIN	Weeks & Leo Co., Inc.	0b606683-7d68-cca5-e063-6394a90a6f58	2025-12-03	Warnings	Exact identifier application number: M012
Capmist DM	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	Capital Pharmaceutical, LLC	63733ac3-859e-4a8e-8717-d852bd303408	2025-12-03	Warnings	Exact identifier application number: M012
ALA-HIST IR	DEXBROMPHENIRAMINE MALEATE	Poly Pharmaceuticals, Inc.	0d203b5c-8b10-428b-8703-17be6b4ce6eb	2025-12-03	Warnings	Exact identifier application number: M012
ALAHIST DM	DEXTROMETHORPHAN HBR, PHENIRAMINE MALEATE, PHENYLEPHRINE HCL	Poly Pharmaceuticals, Inc.	fdaa062d-110e-798d-e053-6394a90a755c	2025-12-03	Warnings	Exact identifier application number: M012
Alahist D	PHENIRAMINE MALEATE, PHENYLEPHRINE HCL	Poly Pharmaceuticals, Inc.	a1b8533a-ef8b-57cc-e053-2995a90a5d9e	2025-12-03	Warnings	Exact identifier application number: M012
Alahist PE	DEXBROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE	Poly Pharmaceuticals, Inc.	ada2d582-5813-2029-e053-2a95a90ae567	2025-12-03	Warnings	Exact identifier application number: M012
Benadryl Allergy Extra Strength Liqui-Gels	DIPHENHYDRAMINE HYDROCHLORIDE	Kenvue Brands LLC	30aca3ab-b091-3939-e063-6294a90a9819	2025-12-03	Warnings	Exact identifier application number: M012
Cough and Cold HBP	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR	L.N.K. International, Inc.	9f2daffc-1904-4d64-9f84-689c88601e06	2025-12-03	Warnings	Exact identifier application number: M012
Childrens Multi-symptom Cold	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Wal-Mart Stores, Inc.	d291faa9-894e-421c-8115-8a8c2a937172	2025-12-03	Warnings	Exact identifier application number: M012
SINUS PAIN AND CONGESTION	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL	CVS Pharmacy	697dffdd-5b56-4395-8e69-6b4360d9fdc5	2025-12-02	Warnings	Exact identifier application number: M012
Maximum Strength Mucus Relief Severe Congestion and Cough	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Wal-Mart Stores,Inc.,	9c8c1974-f931-4493-abb5-ecdc32764ab3	2025-12-02	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