Theraflu

Product NDC: 0067-0123
11-digit product format: 000670123
Labeler code: 0067
Product ID: 0067-0123_682c5a4b-5ded-4276-903f-1ef1141ae518
Type: HUMAN OTC DRUG
Nonproprietary name: acetaminophen, dextromethorphan hbr, diphenhydramine hcl
Dosage form: KIT
Labeler: Haleon US Holdings LLC
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2024-06-01
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
Brand name suffix: Severe Cold Relief Combo Pack
Listing expiration: 2026-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 5 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2670598	Internal RxNorm lookup
2670677	Internal RxNorm lookup
2679420	Internal RxNorm lookup
2679425	Internal RxNorm lookup
2679426	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
682c5a4b-5ded-4276-903f-1ef1141ae518	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
0e2e0f88-b076-afe1-4bdd-32bca4375bec	Product name	3	20250127
43a1ed49-eae2-4840-8075-cb4b33478540	Product name	1	20230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587	Product name	7	20210201
3e48c9c4-918d-5d23-2f0b-d2398b06be54	Product name	1	20140508
76633df9-0d59-4b88-03ed-21dee1b966f8	Product name	1	20140508
865c72dd-0d94-daac-f728-ddd4ded2a79e	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0067-0100-06	TherafluSevere Cold Relief Combo Pack	6 in 1 CARTON	POWDER, FOR SOLUTION		500 mg	1
0067-0100-06	TherafluSevere Cold Relief Combo Pack	1 in 1 PACKET	POWDER, FOR SOLUTION	3	20 mg	1
0067-0101-06	TherafluSevere Cold Relief Combo Pack	6 in 1 CARTON	POWDER, FOR SOLUTION		650 mg	1
0067-0101-06	TherafluSevere Cold Relief Combo Pack	1 in 1 PACKET	POWDER, FOR SOLUTION	1	650 mg	1
0067-0123-01	TherafluSevere Cold Relief Combo Pack	1 in 1 PACKAGE, COMBINATION	KIT	1		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0067-0123	THERAFLU SEVERE COLD RELIEF COMBO PACK (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL) KIT [HALEON US HOLDINGS LLC]	1	Current NDC, 5 package rows	20240704_682c5a4b-5ded-4276-903f-1ef1141ae518.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 164 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
MULTI-SYMPTOM COLD AND FLU RELIEF DAYTIME	ACETAMINOPHEN 325 MG DEXTROMETHORPHAN HBR 10 MG PHENYLEPHRINE HCI 5 MG	RITE AID	c92dbbbb-d149-1e7e-e053-2a95a90a6f1a	2024-04-17	Warnings	Exact identifier application number: M012
MULTI-SYMPTOM COLD AND FLU RELIEF NIGHTTIME	ACETAMINOPHEN 325 MG DEXTROMETHORPHAN HBR 15 MG DOXYLAMINE SUCCINATE 6.25 MG	RITE AID	c9323799-3505-d6c1-e053-2995a90a6f43	2024-04-17	Warnings	Exact identifier application number: M012
Nighttime Cold and Flu Relief	ACETAMINOPHEN DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATE	QUALITY CHOICE (Chain Drug Marketing Association)	fac8b01a-9666-43cc-a4ff-3f3ed452c7e4	2024-04-17	Warnings	Exact identifier application number: M012
Daytime Nighttime Cold and Flu Relief Multi-Symptom	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	P & L Development, LLC	15e9a336-1b34-4f00-9d1c-b945ddf17ed9	2024-04-16	Warnings	Exact identifier application number: M012
Dimetapp Cough and Allergy	DIPHENHYDRAMINE HYDROCHLORIDE	Foundation Consumer Healthcare	15b0f5ff-202a-d19f-e063-6394a90af2b8	2024-04-15	Warnings	Exact identifier application number: M012
Nighttime Severe Cold and Cough	ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL	P & L Development, LLC	8d27b94d-23a1-4e6c-a064-79e2580f7e2e	2024-04-15	Warnings	Exact identifier application number: M012
Severe Cold and Cough Relief Daytime	ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	P & L Development, LLC	2af496a1-6fdd-4acf-9944-8b7cdf302275	2024-04-15	Warnings	Exact identifier application number: M012
Childrens Dye Free Allergy	DIPHENHYDRAMINE HYDROCHLORIDE	P & L Development, LLC	1c4d09ed-4e0f-430d-b17f-6a23f996a55d	2024-04-15	Warnings	Exact identifier application number: M012
Theraflu ExpressMax Daytime Nighttime Value Pack	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL	Haleon US Holdings LLC	9736ad4c-8c2e-421f-b023-f91b72d2828b	2024-04-10	Warnings	Exact identifier application number: M012
Theraflu Multi-Symptom Severe Cold and Theraflu Nighttime Severe Cold and Cough	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, DIPHENHYDRAMINE HCL	Haleon US Holdings LLC	b06b64c5-dbb4-4ef5-af18-3d7d4979c02f	2024-04-10	Warnings	Exact identifier application number: M012
Daytime Nighttime Cold and Flu	ACETAMINOPHEN DEXTROMETHORPHAN HBR PHENYLEPHRINE HCI DOXYLAMINESUCINATE	Harris Teeter, LLC	ec603195-eb36-4b5c-bc9b-c2074205b2b2	2024-04-09	Warnings	Exact identifier application number: M012
Daytime Cold and Flu Non drowsy	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Harris Teeter, LLC	9b0648ac-0ce3-4eaa-8977-26ae864f034d	2024-04-09	Warnings	Exact identifier application number: M012
Theraflu Severe Cold Relief Combo Pack	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL	Haleon US Holdings LLC	f147d82e-4429-4c7b-bd2b-e21a09f21c92	2024-04-09	Warnings	Exact identifier application number: M012
FLONASE Headache and Allergy Relief	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL	Haleon US Holdings LLC	282c103c-3888-4a35-a5b1-d492ed6892c1	2024-04-08	Warnings	Exact identifier application number: M012
ROBITUSSIN COUGH PLUS CHEST CONGESTION DM	DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN	Haleon US Holdings LLC	4908b326-e1da-44ca-8087-7e41a16c27b0	2024-04-08	Warnings	Exact identifier application number: M012
Robitussin Direct Sore Throat Pain	ACETAMINOPHEN	Haleon US Holdings LLC	1b512078-24c3-4b80-8f2c-d6824d367f25	2024-04-08	Warnings	Exact identifier application number: M012
Mucus Relief Cough Childrens	DEXTROMETHORPHAN HBR, GUAIFENSIN	H E B	9ba5ca1b-2e3c-439e-8887-c26f144b88ef	2024-04-08	Warnings	Exact identifier application number: M012
Cold and Flu Relief Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	H E B	12ace982-bd47-49b0-ba1b-e0a29d42f1d6	2024-04-08	Warnings	Exact identifier application number: M012
Allergy Childrens	DIPHENHYDRAMINE HYDROCHLORIDE	H E B	ab28cbc4-7a6f-46e9-8616-be78e8cb24fe	2024-04-08	Warnings	Exact identifier application number: M012
Cold and Flu Relief Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	H E B	bd19b1f2-d9d3-4dab-8181-605f769ab62f	2024-04-08	Warnings	Exact identifier application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2679426	{1 (acetaminophen 500 MG / dextromethorphan hydrobromide 20 MG Granules for Oral Solution) / 1 (acetaminophen 650 MG / diphenhydramine hydrochloride 25 MG Granules for Oral Solution) } Pack	GPCK	682c5a4b-5ded-4276-903f-1ef1141ae518	1
2679426	1 daytime (acetaminophen 500 MG / dextromethorphan HBr 20 MG Granules for Oral Solution) / 1 nighttime (acetaminophen 650 MG / diphenhydrAMINE HCl 25 MG Granules for Oral Solution) Pack	PSN	682c5a4b-5ded-4276-903f-1ef1141ae518	1
2679420	acetaminophen 500 MG / dextromethorphan hydrobromide 20 MG Granules for Oral Solution	PSN	682c5a4b-5ded-4276-903f-1ef1141ae518	1
2670598	acetaminophen 500 MG / dextromethorphan hydrobromide 20 MG Powder for Oral Solution	PSN	682c5a4b-5ded-4276-903f-1ef1141ae518	1
2670677	acetaminophen 650 MG / diphenhydrAMINE HCl 25 MG Powder for Oral Solution	PSN	682c5a4b-5ded-4276-903f-1ef1141ae518	1
2679425	acetaminophen 650 MG / diphenhydrAMINE hydrochloride 25 MG Granules for Oral Solution	PSN	682c5a4b-5ded-4276-903f-1ef1141ae518	1
2679420	acetaminophen 500 MG / dextromethorphan hydrobromide 20 MG Granules for Oral Solution	SCD	682c5a4b-5ded-4276-903f-1ef1141ae518	1
2670598	acetaminophen 500 MG / dextromethorphan hydrobromide 20 MG Powder for Oral Solution	SCD	682c5a4b-5ded-4276-903f-1ef1141ae518	1
2679425	acetaminophen 650 MG / diphenhydramine hydrochloride 25 MG Granules for Oral Solution	SCD	682c5a4b-5ded-4276-903f-1ef1141ae518	1
2670677	acetaminophen 650 MG / diphenhydramine hydrochloride 25 MG Powder for Oral Solution	SCD	682c5a4b-5ded-4276-903f-1ef1141ae518	1
2679426	{1 (acetaminophen 500 MG / dextromethorphan hydrobromide 20 MG Powder for Oral Solution) / 1 (acetaminophen 650 MG / diphenhydramine hydrochloride 25 MG Powder for Oral Solution) } Pack	SY	682c5a4b-5ded-4276-903f-1ef1141ae518	1
2679426	1 daytime (acetaminophen 500 MG / dextromethorphan HBr 20 MG Granules for Oral Solution) / 1 nighttime (acetaminophen 650 MG / diphenhydramine HCl 25 MG Granules for Oral Solution) Pack	SY	682c5a4b-5ded-4276-903f-1ef1141ae518	1
2670677	acetaminophen 650 MG / diphenhydramine HCl 25 MG Granules for Oral Solution	SY	682c5a4b-5ded-4276-903f-1ef1141ae518	1
2670677	acetaminophen 650 MG / diphenhydramine HCl 25 MG Packet for Oral Solution	SY	682c5a4b-5ded-4276-903f-1ef1141ae518	1
2679420	APAP 500 MG / dextromethorphan hydrobromide 20 MG Granules for Oral Solution	SY	682c5a4b-5ded-4276-903f-1ef1141ae518	1
2670598	APAP 500 MG / dextromethorphan hydrobromide 20 MG Powder for Oral Solution	SY	682c5a4b-5ded-4276-903f-1ef1141ae518	1
2679425	APAP 650 MG / diphenhydramine hydrochloride 25 MG Granules for Oral Solution	SY	682c5a4b-5ded-4276-903f-1ef1141ae518	1
2670677	APAP 650 MG / diphenhydramine hydrochloride 25 MG Powder for Oral Solution	SY	682c5a4b-5ded-4276-903f-1ef1141ae518	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
0067-0100-06	00067010006	6 in 1 CARTON					Historical
0067-0101-06	00067010106	6 in 1 CARTON					Historical
0067-0123-01	00067012301	1 KIT in 1 PACKAGE, COMBINATION (0067-0123-01) * 6 PACKET in 1 CARTON (0067-0100-06) / 1 POWDER, FOR SOLUTION in 1 PACKET * 6 PACKET in 1 CARTON (0067-0101-06) / 1 POWDER, FOR SOLUTION in 1 PACKET	1 kit	2024-06-01	No	No	Current