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 163 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Childrens Plus Multi Symptom Cold	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Walgreens	dd967cfb-96b4-4cdc-82e2-a4838001c9e3	2024-05-08	Warnings	Exact identifier application number: M012
Childrens Wal Tap Elixer Cold and Allergy	BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCL	Walgreens	3f438f28-d1ad-44da-a573-f1b0824b051c	2024-05-08	Warnings	Exact identifier application number: M012
Cough Cold and Sore Throat Childrens	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Walgreens	400a0998-e276-4c8d-9b41-145b1b405fff	2024-05-08	Warnings	Exact identifier application number: M012
Mucus Congestion and Cough Relief Childrens	DEXTROMETHORPHAN HBR, GUAIFENSIN, PHENYLEPHRINE HCI	Walgreens	19cd2409-d56b-4319-833c-eacc7dc498c1	2024-05-08	Warnings	Exact identifier application number: M012
Severe Cold and Flu Nighttime Honey	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Kroger	10b12f0e-dba7-fd71-e063-6294a90a42c1	2024-05-06	Warnings	Exact identifier application number: M012
Daytime Nighttime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DEXTROMETHORPHAN HBRDOXYLAMINE SUCCINATE	Kroger	10b15337-b9c5-4dc8-e063-6394a90ac056	2024-05-06	Warnings	Exact identifier application number: M012
Daytime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Kroger	1014da86-3a0e-136f-e063-6294a90ac931	2024-05-04	Warnings	Exact identifier application number: M012
Robitussin Honey Maximum Strength Cough and Chest Congestion DM	DEXTROMETHORPHAN HBR, GUAIFENESIN	Haleon US Holdings LLC	eaa10aed-5b1e-48bf-bc05-7a5638851daf	2024-05-03	Warnings	Exact identifier application number: M012
Theraflu-D Flu Relief Max Strength plus Nasal Decongestant	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PSEUDOEPHEDRINE HCL	Haleon US Holdings LLC	e35cb719-9e7d-4b2b-81a4-29e147dd74fa	2024-05-03	Warnings	Exact identifier application number: M012
Theraflu-D Flu Relief Max Strength plus Nasal Decongestant Nighttime	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PSEUDOEPHEDRINE HCL	Haleon US Holdings LLC	09e20842-2b75-43b9-ae5f-3515b35e655b	2024-05-03	Warnings	Exact identifier application number: M012
Cold and Flu Relief	ACETAMINOPHEN DEXTROMETHORPHAN HBR PHENYLEPHRINE HCL	Family Dollar (FAMILY WELLNESS)	f958d8ba-ede9-4b1a-8317-2404b68a9129	2024-05-03	Warnings	Exact identifier application number: M012
Daytime Nighttime Cold and Flu Relief Multi-Symptom	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	WinCo Foods, LLC	fab57d70-ba54-416f-9f14-b64d2238ea16	2024-05-03	Warnings	Exact identifier application number: M012
Tussin CF Non Drowsy Multi Symptom	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	WinCo Foods, LLC	8ee27600-4f8e-406a-8ea3-eade691448f6	2024-05-03	Warnings	Exact identifier application number: M012
SanaTos Children Cough and Congestion Cherry	DEXTROMETHORPHAN HBR AND GUAIFENESIN	Pharmadel LLC	60437d86-9e13-8d8a-e053-2991aa0a2317	2024-05-02	Warnings	Exact identifier application number: M012
Robitussin Honey Maximum Strength Nighttime Cough DM	DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Haleon US Holdings LLC	0b41da13-18a1-4987-ae43-1319bfa27484	2024-05-01	Warnings	Exact identifier application number: M012
Night Time Cold and Flu Relief Multi Symptom	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	QUALITY CHOICE (Chain Drug Marketing Association)	07c7c0d9-f063-4efc-8a08-2a1bfa9ca84a	2024-05-01	Warnings	Exact identifier application number: M012
Night Time Cold and Flu Multi Symptom	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	QUALITY CHOICE (Chain Drug Marketing Association)	dbfb8971-a122-4a97-a665-e3f0d494876e	2024-05-01	Warnings	Exact identifier application number: M012
Daytime Cold and Flu Non Drowsy	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	P & L Development, LLC	c08b150c-d821-466c-8521-f77535d6af1e	2024-04-30	Warnings	Exact identifier application number: M012
childrens allergy relief	DIPHENHYDRAMINE HYDROCHLORIDE	Walgreen Company	7848bb09-2af8-47f6-b32d-96635a750a55	2024-04-29	Warnings	Exact identifier application number: M012
NASAL and SINUS DECONGESTANT	PHENYLEPHRINE HYDROCHLORIDE	JHK Inc dba American Safety & First Aid	63e51305-2575-49c4-9fda-7b3e1b4b6ede	2024-04-26	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