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 135 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dextromethorphan HBr 15 mg	DEXTROMETHORPHAN HBR	Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.	028b025e-2dde-4bef-ba7b-61774e855b4b	2024-11-21	Warnings	Exact identifier application number: M012
Daytime Severe Cold and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	PuraCap Pharmaceutical LLC	856cb3c3-8f32-4285-8c13-25f01779a31a	2024-11-21	Warnings	Exact identifier application number: M012
Night Time Severe Cold and Flu Relief	ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE, DEXTROMETHORPHAN HYDROBROMIDE	PuraCap Pharmaceutical LLC	3375a059-2939-438e-92b5-a7f1952bbb22	2024-11-21	Warnings	Exact identifier application number: M012
NiteTime Cold/Flu, Multi-Symptom Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Wal-Mart Stores Inc	9033bf94-f444-4488-b717-050d04dee388	2024-11-21	Warnings	Exact identifier application number: M012
Day and Night Sinus Relief Maximum Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Wal-Mart Stores, Inc.	4b554ce8-9a6a-444f-b5ea-63359bbc0653	2024-11-21	Warnings	Exact identifier application number: M012
Day Severe Cold and Night Cold and Flu Maximum Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Wal-Mart Stores, Inc.	7492b381-9eca-4b07-b356-63fdaea14f81	2024-11-21	Warnings	Exact identifier application number: M012
Severe sinus Congestion Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	FOODHOLD U.S.A., LLC	e173bec9-14df-4535-a023-47d8cda8d4ec	2024-11-21	Warnings	Exact identifier application number: M012
COLD FLU and SORE THROAT RELIEF	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	FOODHOLD U.S.A., LLC	1161e5dc-0677-4fb9-964f-971a508098b6	2024-11-21	Warnings	Exact identifier application number: M012
Night Time Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Retail Business Services, LLC	fc8c70d6-6be5-4f12-84b0-125fc82149ec	2024-11-21	Warnings	Exact identifier application number: M012
12 Hour Original Nasal Decongestant	NASAL SPRAY	WinCo Foods LLC	b3b6065a-56da-45e9-b89d-f6553bc181c9	2024-11-21	Warnings	Exact identifier application number: M012
Family Wellness Oxymetazoline Sinus Severe	OXYMETAZOLINE	FAMILY DOLLAR (Family Wellness)	13237d31-c60a-49f8-9b96-4414cf766a08	2024-11-21	Warnings	Exact identifier application number: M012
DayTime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.	5b55d1df-275b-40d8-bde3-fc43313b7eb3	2024-11-20	Warnings	Exact identifier application number: M012
Halls Green Apple	MENTHOL	Mondelez Global LLC	1bb8dcb2-c3a8-a64e-e063-6294a90ae4a2	2024-11-20	Warnings	Exact identifier application number: M012
Halls Blueberry	MENTHOL	Mondelez Global LLC	275a6935-ea44-486e-e063-6394a90ae19a	2024-11-20	Warnings	Exact identifier application number: M012
No Drip Nasal Mist	OXYMETAZOLINE SPRAY	Walgreens Company	234bd567-4e3c-419f-a000-fdfc28cafc8b	2024-11-20	Warnings	Exact identifier application number: M012
NICE Assorted Cough Drops	MENTHOL	Leosons Overseas Corp	96db0f37-41cc-1ebd-e053-2a95a90a3215	2024-11-19	Warnings	Exact identifier application number: M012
Nice Cherry Cough Drops	MENTHOL	Leosons Overseas Corp	98e52604-6e41-6408-e053-2995a90a6bc8	2024-11-19	Warnings	Exact identifier application number: M012
NICE Citrus Cough Drops	MENTHOL	Leosons Overseas Corp	96d9527d-9bf9-ce82-e053-2995a90aff0c	2024-11-19	Warnings	Exact identifier application number: M012
NICE Menthol Cough Drops	MENTHOL	Leosons Overseas Corp	96d77897-475c-482c-e053-2995a90a2da4	2024-11-19	Warnings	Exact identifier application number: M012
NICE Honey Lemon Cough Drops	MENTHOL	Leosons Overseas Corp	96da2c9d-2d0d-6252-e053-2995a90ac338	2024-11-19	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