Theraflu

Product NDC: 0067-0112
11-digit product format: 000670112
Labeler code: 0067
Product ID: 0067-0112_21636332-818b-26bf-e063-6394a90a1925
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen, Diphenhydramine HCl
Dosage form: TABLET, CHEWABLE
Route: ORAL
Labeler: Haleon US Holdings LLC
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2024-09-30
Substance: ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE
Active strength: 325; 12.5 mg/1; mg/1
Pharmacologic classes: Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
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 Nighttime Soft Chews
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ACETAMINOPHEN	325 mg/1
DIPHENHYDRAMINE HYDROCHLORIDE	12.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
362O9ITL9D	Internal UNII lookup
TC2D6JAD40	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2691689	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
6ba64bbe-7599-406a-9187-737c0f8c1c2a	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e0d2eb29-08bd-4bba-90d1-c91c68a38767	Product name	4	20250516
0e2e0f88-b076-afe1-4bdd-32bca4375bec	Product name	3	20250127
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
e92765c1-be81-432a-b909-1b10777ec378	Product name	1	20190208
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
3e48c9c4-918d-5d23-2f0b-d2398b06be54	Product name	1	20140508
865c72dd-0d94-daac-f728-ddd4ded2a79e	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0067-0112-01	TherafluSevere Cold Relief Nighttime Soft Chews	20 in 1 BOTTLE	TABLET, CHEWABLE	20		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0067-0112	THERAFLU SEVERE COLD RELIEF NIGHTTIME SOFT CHEWS (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, CHEWABLE [HALEON US HOLDINGS LLC]	2	Current NDC, 1 package rows	20241001_6ba64bbe-7599-406a-9187-737c0f8c1c2a.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 176 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
NyQuil Severe Plus VapoCOOL Cold and Flu, TRAVEL BASIX	ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HYDROBROMIDE	Lil' Drug Store Products, Inc.	e7355543-6dd7-4560-8fe0-9c1ebd4d2c0b	2023-10-02	Warnings	Exact identifier application number: M012
Guaifenesin DM	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	PD-Rx Pharmaceuticals, Inc.	ac8c0c15-b305-47f2-8712-e4b53636f7fa	2023-10-02	Warnings	Exact identifier application number: M012
Maximum strength Day cold and flu and Night severe cold and flu	ACETAMINOPHE, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, TRIPROLIDINE HCL TABLETS	TIME CAP LABORATORIES,INC	fff69901-965c-5372-e053-6394a90a29c2	2023-09-18	Warnings	Exact identifier application number: M012
Tussin Mucus and Chest Congestion Sugar Free	GUAIFENESIN	AARNA USA, Inc.	6e488782-0138-436d-a9f0-0ec5bc9daedd	2023-05-15	Warnings	Exact identifier application number: M012
MUCUS RELIEF	GUAIFENESIN	KROGER COMPANY	813b1db2-a177-77c6-e053-2a91aa0ac73b	2023-01-17	Warnings	Exact identifier application number: M012
MUCUS RELIEF DM	DEXTROMETHORPHAN HBR/GUAIFENESIN	KROGER COMPANY	813baf42-edb0-33a9-e053-2a91aa0a8599	2023-01-17	Warnings	Exact identifier application number: M012
Daytime Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	H-E-B	db19b8c7-0334-0664-e053-2a95a90ad61f	2023-01-14	Warnings	Exact identifier application number: M012
Nightime	ACETAMINOPHEN DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATE	H-E-B	db44560b-da02-74c9-e053-2a95a90af0b6	2023-01-13	Warnings	Exact identifier application number: M012
DAYTIME COLD AND FLU Maximum Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HBR,GUAIFENESIN, PHENYLEPHRINE HCL	Walgreens	dbf5656b-9105-871b-e053-2995a90a4941	2023-01-03	Warnings	Exact identifier application number: M012
DAYTIME-NIGHTTIME SEVERE COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	KROGER	a2508699-08c0-4a22-e053-2a95a90a8a6d	2022-11-02	Warnings	Exact identifier application number: M012
GUAIFENESIN	GUAIFENESIN	PAI Holdings, LLC dba PAI Pharma	c2e53fb5-2798-47c8-9285-d1077d46e629	2022-06-14	Warnings	Exact identifier application number: M012
Mucus Relief DM	MUCUS RELIEF DM	TopCo Associates, LLC	71674a9b-89ed-43d1-aadb-b9311fdfbdf9	2022-06-07	Warnings	Exact identifier application number: M012
Daytime Nighttime Cold and Flu Relief Combo Pack	DAYTIME NIGHTTIME COLD AND FLU	Allegiant Health	fa7ed5db-4da7-46b4-a08d-1d79cb7a5674	2022-05-19	Warnings	Exact identifier application number: M012
Mucus Relief DM Immediate Release	MUCUS RELIEF DM	Good Sense	26a199bf-57e5-4f36-b40c-83a1187e4870	2022-05-18	Warnings	Exact identifier application number: M012
Mucus Relief DM Immediate Release	MUCUS RELIEF DM	Allegiant Health	731f8608-ad5b-491e-a4d4-2bb0c423fed5	2022-05-18	Warnings	Exact identifier application number: M012
Acetaminophen, Chlorpheniramine Maleate, Phenylephrine HCl	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL	OPMX LLC	b3c229a4-c772-70fb-e053-2a95a90a72db	2022-03-11	Warnings	Exact identifier application number: M012
Allergy Relief	CHLORPHENIRAMINE MALEATE	Good Sense	f88e2654-8e97-4cf6-9c36-01aeb51a9102	2021-11-30	Warnings	Exact identifier application number: M012
Cold Medicine	COLD MEDICINE	Allegiant Health	443fbc44-2c33-4316-ad31-dcc5a5aa8f52	2021-11-23	Warnings	Exact identifier application number: M012
Decongestant PE Non Drowsy	PHENYLEPHRINE HCL	Allegiant Health	7a3098b4-381c-4f32-97a7-87b53fd64428	2021-06-16	Warnings	Exact identifier application number: M012
Mucus Relief Immediate Release	GUAIFENESIN 400MG	Good Sense	e7c68746-7ec0-46cf-b4a3-174fab819b5e	2021-05-05	Warnings	Exact identifier application number: M012

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
362O9ITL9D	ACETAMINOPHEN	103-90-2	ACETAMINOPHEN
TC2D6JAD40	DIPHENHYDRAMINE HYDROCHLORIDE	147-24-0	DIPHENHYDRAMINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2691689	acetaminophen 325 MG / diphenhydrAMINE HCl 12.5 MG Chewable Tablet	PSN	6ba64bbe-7599-406a-9187-737c0f8c1c2a	2
2691689	acetaminophen 325 MG / diphenhydramine hydrochloride 12.5 MG Chewable Tablet	SCD	6ba64bbe-7599-406a-9187-737c0f8c1c2a	2
2691689	APAP 325 MG / diphenhydramine hydrochloride 12.5 MG Chewable Tablet	SY	6ba64bbe-7599-406a-9187-737c0f8c1c2a	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
0067-0112-01	00067011201	20 TABLET, CHEWABLE in 1 BOTTLE (0067-0112-01)	2024-09-30	No	No	Current