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

Product NDC: 0067-7919
11-digit product format: 000677919
Labeler code: 0067
Product ID: 0067-7919_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
0067-7919-12	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	1422 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
0067-7919-12	Theraflu Multi-Symptom Severe Cold and Theraflu Nighttime Severe Cold and Cough	1 in 1 PACKAGE, COMBINATION	KIT	1		8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0067-7919-12	EA - Each	0067-7919	c3543916-1f06-4092-a2a0-375e13ce1fd8	1	2018-04-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0067-7919	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 74 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
cherry cough drops	MENTHOL	Meijer	5bc2ec81-a3cb-3a59-e053-2a91aa0ac14e	2025-12-18	Warnings	Exact identifier application number: M012
cherry cough drops	MENTHOL	Meijer	5bc3b9b8-e61e-1041-e053-2a91aa0a3d83	2025-12-18	Warnings	Exact identifier application number: M012
honey lemon cough drops	MENTHOL	Meijer	5bd35bce-cd85-5314-e053-2991aa0abce6	2025-12-18	Warnings	Exact identifier application number: M012
honey lemon cough drops	MENTHOL	Meijer	5bd42654-56e5-997e-e053-2a91aa0afd34	2025-12-18	Warnings	Exact identifier application number: M012
sugar free menthol cough drops	MENTHOL	Meijer	5bd61cd4-a5ca-9d66-e053-2a91aa0a93a3	2025-12-18	Warnings	Exact identifier application number: M012
sugar free honey lemon cough drops	MENTHOL	Meijer	5bd7c24d-6a61-5d2d-e053-2a91aa0a08ed	2025-12-18	Warnings	Exact identifier application number: M012
SF Honey Lemon Cough Drops	MENTHOL	Meijer Distribution	70e3de9a-1804-ef15-e053-2a95a90a3340	2025-12-18	Warnings	Exact identifier application number: M012
QUALITY CHOICE Cough Drops Vanilla Honey	MENTHOL	Chain Drug Marketing Association, Inc.	3d6a4bcc-1044-40f5-928a-378ececcb687	2025-12-18	Warnings	Exact identifier application number: M012
Meijer Strawberry Cough Drops	MENTHOL	Meijer	164de637-e644-711c-e063-6294a90a1c5f	2025-12-18	Warnings	Exact identifier application number: M012
Meijer Severe Menthol Throat Drops	MENTHOL	Meijer	16603ca4-1ce5-2e7e-e063-6394a90ad6f1	2025-12-18	Warnings	Exact identifier application number: M012
Allergy Relief Childrens	DIPHENHYDRAMINE HCL	A-S Medication Solutions	60587987-c303-4617-ba96-c518ab2a0650	2025-12-18	Warnings	Exact identifier application number: M012
Niaflu	DEXTROMETHORPHAN HBR, GUAIFENESIN	Pharmadel LLC	399898f0-e40a-4f5d-e063-6294a90a667d	2025-12-17	Warnings	Exact identifier application number: M012
Cherry cough drop	MENTHOL	The Kroget Co.	4313a6ce-454d-4c4b-e054-00144ff88e88	2025-12-17	Warnings	Exact identifier application number: M012
Menthol cough drop	MENTHOL	The Kroger Co.	42b257e9-f45e-32c9-e054-00144ff8d46c	2025-12-17	Warnings	Exact identifier application number: M012
Honey Lemon cough drop	MENTHOL	The Kroger Co.	4318f25a-05d9-2208-e054-00144ff88e88	2025-12-17	Warnings	Exact identifier application number: M012
Honey Lemon cough drop	MENTHOL	The Kroger Co.	4317f952-a228-0281-e054-00144ff88e88	2025-12-17	Warnings	Exact identifier application number: M012
Honey Lemon Cough Drop	MENTHOL	The Kroger Co.	4316df6e-3ae6-4ab5-e054-00144ff88e88	2025-12-17	Warnings	Exact identifier application number: M012
SF Honey Lemon Cough Drops	MENTHOL	The Kroger Co.	43281bd1-f8a7-02a4-e054-00144ff8d46c	2025-12-17	Warnings	Exact identifier application number: M012
Kroger Cherry Cough Drops	MENTHOL	Kroger	a2e1d1f5-9b19-1704-e053-2a95a90abb51	2025-12-17	Warnings	Exact identifier application number: M012
Tussin Multi Symptom Cold CF Adult	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE	Major Pharmaceuticals	a9958b7d-7060-422b-a098-c1925c246081	2025-12-17	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
0067-7919-12	00067791912	1 KIT in 1 PACKAGE, COMBINATION (0067-7919-12) * 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	2016-01-01	0000-00-00	No	No	Current