Theraflu Multi-Symptom Severe Cold and Theraflu Nighttime Severe Cold and Cough

Product NDC: 0067-8200
11-digit product format: 000678200
Labeler code: 0067
Product ID: 0067-8200_15bf1214-572a-f6b6-e063-6394a90ab0cb
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl, Diphenhydramine HCl
Dosage form: KIT
Labeler: Haleon US Holdings LLC
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2016-01-01
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 Multi-Symptom Severe Cold and Theraflu Nighttime Severe Cold and Cough
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
1189316	Internal RxNorm lookup
1659960	Internal RxNorm lookup
2640034	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
b06b64c5-dbb4-4ef5-af18-3d7d4979c02f	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
05a8cdd1-eeb8-409e-b938-0778225eca7d	Product name	4	20250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9	Product name	8	20250220
0e2e0f88-b076-afe1-4bdd-32bca4375bec	Product name	3	20250127
f489e8f3-5c9e-4818-b539-a73587edcfc7	Product name	2	20240229
0f7ae452-206d-4fc4-868d-56fc47074084	Product name	1	20231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3df	Product name	2	20190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814	Product name	3	20150910
3e48c9c4-918d-5d23-2f0b-d2398b06be54	Product name	1	20140508
42f3c020-f1b3-89bc-7bdc-e1f10e680485	Product name	1	20140508
865c72dd-0d94-daac-f728-ddd4ded2a79e	Product name	1	20140508
e949165d-714d-e548-2b76-0cb5def16f30	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0067-8200-01	2024-01-30	C162847	48780-1	1030e365-54e7-111a-e063-dadaa90a10e2	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0067-6426-01	Theraflu Multi-Symptom Severe Cold and Theraflu Nighttime Severe Cold and Cough	237 mL in 1 PACKET	POWDER, FOR SOLUTION	4266 mL	500 mg in 237mL	8
0067-6426-06	Theraflu Multi-Symptom Severe Cold and Theraflu Nighttime Severe Cold and Cough	6 in 1 CARTON	POWDER, FOR SOLUTION		500 mg in 237mL	8
0067-7918-01	Theraflu Multi-Symptom Severe Cold and Theraflu Nighttime Severe Cold and Cough	237 mL in 1 PACKET	POWDER, FOR SOLUTION	1422 mL	650 mg in 237mL	8
0067-7918-06	Theraflu Multi-Symptom Severe Cold and Theraflu Nighttime Severe Cold and Cough	6 in 1 CARTON	POWDER, FOR SOLUTION		650 mg in 237mL	8
0067-8200-01	Theraflu Multi-Symptom Severe Cold and Theraflu Nighttime Severe Cold and Cough	1 in 1 PACKAGE, COMBINATION	KIT	1		8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0067-8200	THERAFLU MULTI-SYMPTOM SEVERE COLD AND THERAFLU NIGHTTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, DIPHENHYDRAMINE HCL) KIT [HALEON US HOLDINGS LLC]	8	Current NDC, Legacy NDC, 5 package rows	20240411_b06b64c5-dbb4-4ef5-af18-3d7d4979c02f.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 20 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	Health Pharma USA LLC	319e84fd-4033-f5eb-e063-6394a90aa2f3	2026-06-27	Warnings	Exact identifier application number: M012
HyVee Cough Drops Menthol	MENTHOL	HY-VEE, INC	47a6f3c3-a6fa-dd61-e063-6394a90a4965	2026-06-26	Warnings	Exact identifier application number: M012
HyVee Cough Drops Cherry	MENTHOL	HY-VEE, INC	47a717e9-56b3-e771-e063-6394a90a5c17	2026-06-26	Warnings	Exact identifier application number: M012
Calmco Allergy Relief	DIPHENHYDRAMINE HCL	CalmCo LLC	5532fd37-cdd6-97ab-e063-6394a90a3c77	2026-06-26	Warnings	Exact identifier application number: M012
Dr Kids Allergy Relief	DIPHENHYDRAMINE HCL	CalmCo LLC	5533e705-b8d5-71cf-e063-6394a90a2010	2026-06-26	Warnings	Exact identifier application number: M012
Acetaminophen, Diphenhydramine Hydrochloride, and Phenylephrine Hydrochloride	ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE	HHH Pharmaceuticals	265f1ce7-160c-4dda-b2e0-b78d68f962bd	2026-06-26	Warnings	Exact identifier application number: M012
Allergy Relief	CHLORPHENIRAMINE MALEATE	Bryant Ranch Prepack	ee052b39-1658-4071-b081-5433c87b5e4a	2026-06-25	Warnings	Exact identifier application number: M012
Allergy Multi-Symptom	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HCL	DOLGENCORP, LLC	fae1499a-7029-4208-8436-4d330347b915	2026-06-25	Warnings	Exact identifier application number: M012
Sinus Pressure and Pain Maximum Strength	ACETAMINOPHEN, PHENYLEPHRINE HCL	DOLGENCORP, LLC	4fe8f124-ac80-40b4-8e1d-96709c459a4f	2026-06-25	Warnings	Exact identifier application number: M012
Allergy and Sinus Headache	ACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCL	ARMY AND AIR FORCE EXCHANGE SERVICE	91268cd0-c151-4744-a715-a57af3f3a314	2026-06-25	Warnings	Exact identifier application number: M012
Cold and Flu Severe	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Meijer Distribution, Inc.	a3c4b9c3-bdb1-4f79-bee6-1bb6bec215ea	2026-06-24	Warnings	Exact identifier application number: M012
Cold and Flu Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	ARMY AND AIR FORCE EXCHANGE SERVICE	cb475e7f-aec1-415d-9770-07cce4e02c07	2026-06-24	Warnings	Exact identifier application number: M012
Broncolito Children	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Pharmadel LLC	509f5b72-9894-ef44-e063-6394a90a6d07	2026-06-23	Warnings	Exact identifier application number: M012
Neo-Synephrine Severe	PHENYLEPHRINE HYDROCHLORIDE	BF ASCHER AND CO INC	54edaff7-d241-dc90-e063-6294a90ac64d	2026-06-23	Warnings	Exact identifier application number: M012
AXIV Sinus Severe Ultra Fine Mist	OXYMETAZOLINE HYDROCHLORIDE.	VIVUNT PHARMA LLC	4b81abf9-3ea7-e996-e063-6394a90a71e8	2026-06-23	Warnings	Exact identifier application number: M012
AXIV Sinus OVERNIGHT	OXYMETAZOLINE HYDROCHLORIDE.	VIVUNT PHARMA LLC	54e03a63-f978-33d4-e063-6394a90a30f2	2026-06-23	Warnings	Exact identifier application number: M012
equaline daytime cold and flu relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	United Natural Foods, Inc. dba UNFI	9a199782-5d7e-449b-a86c-969746f0e96f	2026-06-23	Warnings	Exact identifier application number: M012
Cough and Cold HBP	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR	Walgreen Company	542b9861-8055-45f6-8cbf-9fe5cde1c4d9	2026-06-23	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	BIONPHARMA INC.	3c1953a1-32e9-6c81-e063-6294a90a9fa2	2026-06-22	Warnings	Exact identifier application number: M012
DAYTIME COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	59db2573-7ebb-4cf9-bfe3-428929bb4eeb	2026-06-22	Warnings	Exact identifier application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2640034	{1 (acetaminophen 500 MG / dextromethorphan hydrobromide 20 MG / phenylephrine hydrochloride 10 MG Granules for Oral Solution) / 1 (acetaminophen 650 MG / diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 10 MG Granules for Oral Solution) } Pack	GPCK	b06b64c5-dbb4-4ef5-af18-3d7d4979c02f	8
2640034	1 daytime (acetaminophen 500 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG Granules for Oral Solution) / 1 nighttime (acetaminophen 650 MG / diphenhydrAMINE HCl 25 MG / phenylephrine HCl 10 MG Granules for Oral Solution) Pack	PSN	b06b64c5-dbb4-4ef5-af18-3d7d4979c02f	8
1189316	acetaminophen 500 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG Granules for Oral Solution	PSN	b06b64c5-dbb4-4ef5-af18-3d7d4979c02f	8
1659960	acetaminophen 650 MG / diphenhydrAMINE HCl 25 MG / phenylephrine HCl 10 MG Granules for Oral Solution	PSN	b06b64c5-dbb4-4ef5-af18-3d7d4979c02f	8
1189316	acetaminophen 500 MG / dextromethorphan hydrobromide 20 MG / phenylephrine hydrochloride 10 MG Granules for Oral Solution	SCD	b06b64c5-dbb4-4ef5-af18-3d7d4979c02f	8
1659960	acetaminophen 650 MG / diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 10 MG Granules for Oral Solution	SCD	b06b64c5-dbb4-4ef5-af18-3d7d4979c02f	8
2640034	1 daytime (acetaminophen 500 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG Granules for Oral Solution) / 1 nighttime (acetaminophen 650 MG / diphenhydramine HCl 25 MG / phenylephrine HCl 10 MG Granules for Oral Solution) Pack	SY	b06b64c5-dbb4-4ef5-af18-3d7d4979c02f	8
1189316	acetaminophen 500 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG Packet for Oral Solution	SY	b06b64c5-dbb4-4ef5-af18-3d7d4979c02f	8
1189316	acetaminophen 500 MG / dextromethorphan hydrobromide 20 MG / phenylephrine hydrochloride 10 MG Powder for Oral Solution	SY	b06b64c5-dbb4-4ef5-af18-3d7d4979c02f	8
1659960	acetaminophen 650 MG / diphenhydramine HCl 25 MG / phenylephrine HCl 10 MG Packet for Oral Solution	SY	b06b64c5-dbb4-4ef5-af18-3d7d4979c02f	8
1659960	acetaminophen 650 MG / diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 10 MG Powder for Oral Solution	SY	b06b64c5-dbb4-4ef5-af18-3d7d4979c02f	8
1189316	APAP 500 MG / Dextromethorphan Hydrobromide 20 MG / Phenylephrine Hydrochloride 10 MG Granules for Oral Solution	SY	b06b64c5-dbb4-4ef5-af18-3d7d4979c02f	8
1659960	APAP 650 MG / Diphenhydramine Hydrochloride 25 MG / Phenylephrine Hydrochloride 10 MG Granules for Oral Solution	SY	b06b64c5-dbb4-4ef5-af18-3d7d4979c02f	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0067-6426-01	00067642601	237 mL in 1 PACKET	237 ml					Historical
0067-6426-06	00067642606	6 in 1 CARTON						Historical
0067-7918-01	00067791801	237 mL in 1 PACKET	237 ml					Historical
0067-7918-06	00067791806	6 in 1 CARTON						Historical
0067-8200-01	00067820001	1 KIT in 1 PACKAGE, COMBINATION (0067-8200-01) * 6 PACKET in 1 CARTON (0067-6426-06) / 237 mL in 1 PACKET (0067-6426-01) * 6 PACKET in 1 CARTON (0067-7918-06) / 237 mL in 1 PACKET (0067-7918-01)	1 kit	2019-09-01	0000-00-00	No	No	Current