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 53 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Foster and Thrive Cherry Cough Drops	MENTHOL	McKesson	49eefa70-cef9-d7ec-e063-6294a90ac321	2026-02-03	Warnings	Exact identifier application number: M012
Foster and Thrive Honey Lemon Cough Drops	MENTHOL	McKesson	49f13ee3-6bb3-e500-e063-6394a90a152d	2026-02-03	Warnings	Exact identifier application number: M012
Daytime Cold and Flu Mini Softgels	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Shield Pharmaceuticals Corp	63cb19d4-2306-4723-a95e-9d2d8b9eccd0	2026-02-03	Warnings	Exact identifier application number: M012
Foster and Thrive SF Honey Lemon Cough Drops	MENTHOL	McKesson	49f41c30-f806-44ba-e063-6394a90a5a67	2026-02-03	Warnings	Exact identifier application number: M012
Nighttime Cold and Flu Mini Softgels	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Shield Pharmaceuticals Corp	b9af8ab4-a7cb-4adf-9f6f-398c6bb7f853	2026-02-03	Warnings	Exact identifier application number: M012
allergy relief	DIPHENHYDRAMINE HCL	Meijer Distribution Inc	7c2fc244-bfc5-4e3c-aa90-8bc3d067b64f	2026-02-03	Warnings	Exact identifier application number: M012
Cold and Allergy D	PSEUDOEPHEDRINE HCL, TRIPROLIDINE HCL	Walgreen Company	832ac849-7f4a-489a-a704-9d4388a75a71	2026-02-03	Warnings	Exact identifier application number: M012
severe cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	HyVee Inc	987f908b-7af7-4705-bfb4-c48d771c380d	2026-02-03	Warnings	Exact identifier application number: M012
tussin dm nighttime max	DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	HyVee Inc	1f3fb451-84c9-432e-ac67-2694dd66c815	2026-02-03	Warnings	Exact identifier application number: M012
Robafen DM Cough	DEXTROMETHORPHAN HBR, GUAIFENESIN	Major Pharmaceuticals	7c9660b7-cb00-449b-b65f-aa42d8ce1942	2026-02-03	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	Walgreen Company	6b0d261f-fc27-4b34-88b1-cd3d72766760	2026-02-02	Warnings	Exact identifier application number: M012
Tussin DM	DEXTROMETHORPHAN HBR, GUAIFENESIN	Cardinal Health 110, LLC. DBA Leader	ebfcb699-3369-4697-9841-44015b1c9808	2026-02-02	Warnings	Exact identifier application number: M012
Cherry Sore Throat Lozenges	BENZOCAINE, MENTHOL	Meijer Distribution Inc.	2f6de590-7cad-25d7-e054-00144ff8d46c	2026-02-02	Warnings	Exact identifier application number: M012
Mixed Berry Sore Throat and Cough lozenge	DEXTROMETHORPHAN HYDROBROMIDE	Meijer Distribution, Inc.	304ff4db-201a-60a4-e054-00144ff8d46c	2026-02-02	Warnings	Exact identifier application number: M012
Allergy Relief Plus Congestion	DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL	Walgreen Company	38d91107-d95c-40f2-a27e-561f951e519d	2026-02-02	Warnings	Exact identifier application number: M012
Tussin Severe	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	HyVee Inc	85252999-3463-45fe-b4a9-7a97960b41b1	2026-02-02	Warnings	Exact identifier application number: M012
Amazon Basics Cherry Cough Drops 30ct	MENTHOL	Amazon	3e74e209-c9c9-3979-e063-6294a90afcfa	2026-02-01	Warnings	Exact identifier application number: M012
Amazon Basics Honey Lemon Cough Drops 30ct	MENTHOL	Amazon	3e75838b-e1c9-2d42-e063-6294a90aab82	2026-02-01	Warnings	Exact identifier application number: M012
cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	HyVee Inc	5110526f-51fd-401e-ba52-520674d34f37	2026-02-01	Warnings	Exact identifier application number: M012
Chest Rub	CAMPHOR, EUCALYPTUS OIL, MENTHOL	Amazon.com Service LLC	673996ab-6e57-4feb-8af3-d8b474741a8d	2026-01-30	Warnings, Adverse reactions	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