Theraflu ExpressMax

Product NDC: 0067-8129
11-digit product format: 000678129
Labeler code: 0067
Product ID: 0067-8129_131827e6-0141-cf1d-e063-6294a90ae248
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl
Dosage form: SYRUP
Route: ORAL
Labeler: Haleon US Holdings LLC
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2015-07-15
Substance: ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength: 650; 25; 10 mg/30mL; mg/30mL; mg/30mL
Pharmacologic classes: Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-1 Adrenergic Agonist [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 ExpressMax
Brand name suffix: Nighttime Severe Cold and Cough
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ACETAMINOPHEN	650 mg/30mL
DIPHENHYDRAMINE HYDROCHLORIDE	25 mg/30mL
PHENYLEPHRINE HYDROCHLORIDE	10 mg/30mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
362O9ITL9D	Internal UNII lookup
TC2D6JAD40	Internal UNII lookup
04JA59TNSJ	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1298348	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
f5a66541-1b15-4dfe-91e0-d8d5f8fdc7fb	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
bf324df6-7127-7deb-def5-2681c136cd03	Product name	3	20250325
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
43a1ed49-eae2-4840-8075-cb4b33478540	Product name	1	20230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587	Product name	7	20210201
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
76633df9-0d59-4b88-03ed-21dee1b966f8	Product name	1	20140508
865c72dd-0d94-daac-f728-ddd4ded2a79e	Product name	1	20140508
e949165d-714d-e548-2b76-0cb5def16f30	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0067-8129-08	Theraflu ExpressMaxNighttime Severe Cold and Cough	245.5 mL in 1 BOTTLE	SYRUP	245.5		7
0067-8129-08	Theraflu ExpressMaxDaytime Nighttime Value Pack	245.5 mL in 1 BOTTLE	SYRUP	245.5 mL	650 mg in 30mL	5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0067-8129-08	ML - Milliliter	0067-8129	d2541d5a-5905-40e7-bf8a-81fdf97222a8	1	2016-03-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	THERAFLU EXPRESSMAX NIGHTTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) SYRUP [NOVARTIS CONSUMER HEALTH, INC.]	2
DIPHENHYDRAMINE HYDROCHLORIDE	ACTIVE INGREDIENT	TC2D6JAD40	THERAFLU EXPRESSMAX NIGHTTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) SYRUP [NOVARTIS CONSUMER HEALTH, INC.]	2
PHENYLEPHRINE HYDROCHLORIDE	ACTIVE INGREDIENT	04JA59TNSJ	THERAFLU EXPRESSMAX NIGHTTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) SYRUP [NOVARTIS CONSUMER HEALTH, INC.]	2
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	THERAFLU EXPRESSMAX NIGHTTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) SYRUP [NOVARTIS CONSUMER HEALTH, INC.]	2
DIPHENHYDRAMINE	ACTIVE MOIETY	8GTS82S83M	THERAFLU EXPRESSMAX NIGHTTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) SYRUP [NOVARTIS CONSUMER HEALTH, INC.]	2
PHENYLEPHRINE	ACTIVE MOIETY	1WS297W6MV	THERAFLU EXPRESSMAX NIGHTTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) SYRUP [NOVARTIS CONSUMER HEALTH, INC.]	2
ACESULFAME POTASSIUM	INACTIVE INGREDIENT	23OV73Q5G9	THERAFLU EXPRESSMAX NIGHTTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) SYRUP [NOVARTIS CONSUMER HEALTH, INC.]	2
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	THERAFLU EXPRESSMAX NIGHTTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) SYRUP [NOVARTIS CONSUMER HEALTH, INC.]	2
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	THERAFLU EXPRESSMAX NIGHTTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) SYRUP [NOVARTIS CONSUMER HEALTH, INC.]	2
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	THERAFLU EXPRESSMAX NIGHTTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) SYRUP [NOVARTIS CONSUMER HEALTH, INC.]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	THERAFLU EXPRESSMAX NIGHTTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) SYRUP [NOVARTIS CONSUMER HEALTH, INC.]	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	THERAFLU EXPRESSMAX NIGHTTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) SYRUP [NOVARTIS CONSUMER HEALTH, INC.]	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	THERAFLU EXPRESSMAX NIGHTTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) SYRUP [NOVARTIS CONSUMER HEALTH, INC.]	2
MALTITOL	INACTIVE INGREDIENT	D65DG142WK	THERAFLU EXPRESSMAX NIGHTTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) SYRUP [NOVARTIS CONSUMER HEALTH, INC.]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	THERAFLU EXPRESSMAX NIGHTTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) SYRUP [NOVARTIS CONSUMER HEALTH, INC.]	2
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	THERAFLU EXPRESSMAX NIGHTTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) SYRUP [NOVARTIS CONSUMER HEALTH, INC.]	2
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	THERAFLU EXPRESSMAX NIGHTTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) SYRUP [NOVARTIS CONSUMER HEALTH, INC.]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	THERAFLU EXPRESSMAX NIGHTTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) SYRUP [NOVARTIS CONSUMER HEALTH, INC.]	2
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	THERAFLU EXPRESSMAX DAYTIME NIGHTTIME VALUE PACK (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) KIT [NOVARTIS CONSUMER HEALTH, INC.]	1
DEXTROMETHORPHAN HYDROBROMIDE	ACTIVE INGREDIENT	9D2RTI9KYH	THERAFLU EXPRESSMAX DAYTIME NIGHTTIME VALUE PACK (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) KIT [NOVARTIS CONSUMER HEALTH, INC.]	1
DIPHENHYDRAMINE HYDROCHLORIDE	ACTIVE INGREDIENT	TC2D6JAD40	THERAFLU EXPRESSMAX DAYTIME NIGHTTIME VALUE PACK (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) KIT [NOVARTIS CONSUMER HEALTH, INC.]	1
PHENYLEPHRINE HYDROCHLORIDE	ACTIVE INGREDIENT	04JA59TNSJ	THERAFLU EXPRESSMAX DAYTIME NIGHTTIME VALUE PACK (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) KIT [NOVARTIS CONSUMER HEALTH, INC.]	1
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	THERAFLU EXPRESSMAX DAYTIME NIGHTTIME VALUE PACK (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) KIT [NOVARTIS CONSUMER HEALTH, INC.]	1
DEXTROMETHORPHAN	ACTIVE MOIETY	7355X3ROTS	THERAFLU EXPRESSMAX DAYTIME NIGHTTIME VALUE PACK (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) KIT [NOVARTIS CONSUMER HEALTH, INC.]	1
DIPHENHYDRAMINE	ACTIVE MOIETY	8GTS82S83M	THERAFLU EXPRESSMAX DAYTIME NIGHTTIME VALUE PACK (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) KIT [NOVARTIS CONSUMER HEALTH, INC.]	1
PHENYLEPHRINE	ACTIVE MOIETY	1WS297W6MV	THERAFLU EXPRESSMAX DAYTIME NIGHTTIME VALUE PACK (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) KIT [NOVARTIS CONSUMER HEALTH, INC.]	1
ACESULFAME POTASSIUM	INACTIVE INGREDIENT	23OV73Q5G9	THERAFLU EXPRESSMAX DAYTIME NIGHTTIME VALUE PACK (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) KIT [NOVARTIS CONSUMER HEALTH, INC.]	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	THERAFLU EXPRESSMAX DAYTIME NIGHTTIME VALUE PACK (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) KIT [NOVARTIS CONSUMER HEALTH, INC.]	1
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	THERAFLU EXPRESSMAX DAYTIME NIGHTTIME VALUE PACK (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) KIT [NOVARTIS CONSUMER HEALTH, INC.]	1
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	THERAFLU EXPRESSMAX DAYTIME NIGHTTIME VALUE PACK (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) KIT [NOVARTIS CONSUMER HEALTH, INC.]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	THERAFLU EXPRESSMAX DAYTIME NIGHTTIME VALUE PACK (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) KIT [NOVARTIS CONSUMER HEALTH, INC.]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	THERAFLU EXPRESSMAX DAYTIME NIGHTTIME VALUE PACK (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) KIT [NOVARTIS CONSUMER HEALTH, INC.]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	THERAFLU EXPRESSMAX DAYTIME NIGHTTIME VALUE PACK (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) KIT [NOVARTIS CONSUMER HEALTH, INC.]	1
MALTITOL	INACTIVE INGREDIENT	D65DG142WK	THERAFLU EXPRESSMAX DAYTIME NIGHTTIME VALUE PACK (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) KIT [NOVARTIS CONSUMER HEALTH, INC.]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	THERAFLU EXPRESSMAX DAYTIME NIGHTTIME VALUE PACK (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) KIT [NOVARTIS CONSUMER HEALTH, INC.]	1
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	THERAFLU EXPRESSMAX DAYTIME NIGHTTIME VALUE PACK (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) KIT [NOVARTIS CONSUMER HEALTH, INC.]	1
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	THERAFLU EXPRESSMAX DAYTIME NIGHTTIME VALUE PACK (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) KIT [NOVARTIS CONSUMER HEALTH, INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	THERAFLU EXPRESSMAX DAYTIME NIGHTTIME VALUE PACK (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) KIT [NOVARTIS CONSUMER HEALTH, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0067-8129	THERAFLU EXPRESSMAX NIGHTTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) SYRUP [HALEON US HOLDINGS LLC]	7	Current NDC, Legacy NDC, 1 package rows	20240308_f5a66541-1b15-4dfe-91e0-d8d5f8fdc7fb.zip
0067-8129	THERAFLU EXPRESSMAX DAYTIME NIGHTTIME VALUE PACK (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) KIT [HALEON US HOLDINGS LLC]	5	Current NDC, Legacy NDC	20240411_9736ad4c-8c2e-421f-b023-f91b72d2828b.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 118 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
HISTEX-DM New Formulation	DEXTROMETHORPHAN HBR, PSEUDOEPHEDRINE HCI, AND TRIPROLIDINE HCI	Allegis Pharmaceuticals, LLC	30010401-e5b4-2bd9-e063-6394a90a0b0b	2025-03-10	Warnings	Exact identifier application number: M012
daytime severe cold multi-symptom	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	United Natural Foods, Inc. dba UNFI	cc7c5f1c-76b7-4278-8e2a-5fbc85e022dd	2025-03-08	Warnings	Exact identifier application number: M012
Cold and Head Congestion Relief Severe	ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL	WinCo Foods, LLC	a39778ba-1f63-4495-8e9b-44b0bdd7f71a	2025-03-08	Warnings	Exact identifier application number: M012
Extra Strength TYLENOL Severe Cough Plus Sore Throat Day	ACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDE	Kenvue Brands LLC	2e9540e4-bd1d-9370-e063-6294a90affcb	2025-03-07	Warnings	Exact identifier application number: M012
Herbal Cough Drops Original Herb	COUGH DROPS	Topco Associates LLC	2fb22181-aee3-d0bf-e063-6294a90a7865	2025-03-06	Warnings	Exact identifier application number: M012
REVASOL DAYTIME COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Rnv LLC	2f9ddcc3-b913-f8b0-e063-6294a90a93ab	2025-03-05	Warnings	Exact identifier application number: M012
Herbal Throat Drops Lemon Mint Herb	THROAT DROPS	Topco Associates LLC	2fa086b4-3b0e-0df8-e063-6294a90a6769	2025-03-05	Warnings	Exact identifier application number: M012
Redicare Nasal and Sinus Decongestant	REDICARE NASAL AND SINUS DECONGESTANT	Redicare LLC	2f24be68-f30e-d916-e063-6294a90a7e31	2025-03-04	Warnings	Exact identifier application number: M012
Diphenhydramine HCl Oral Solution	DIPHENHYDRAMINE HCL ORAL SOLUTION	Kesin Pharma Corporation	2f871005-de4d-8b2a-e063-6394a90aa43a	2025-03-04	Warnings	Exact identifier application number: M012
CVS Daytime Cough Relief Chews - Citrus Punch	DEXTROMETHORPHAN HBR	CVS	2f885f1b-7ff5-251b-e063-6394a90a656f	2025-03-04	Warnings	Exact identifier application number: M012
CVS Dex-Dox Kids Nighttime Cough Suppressant	DEXTROMETHORPHAN HBR	CVS	2f8b6f5e-399c-b033-e063-6294a90ac3d1	2025-03-04	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL 25 MG	Pioneer Life Sciences, LLC	ff8b096c-8f01-4a8c-a98f-e4aa4d688e95	2025-03-04	Warnings	Exact identifier application number: M012
Menthol Cough Drops Honey Vanilla Flavor	MENTHOL	7-ELEVEN	2f3c43dd-175f-722e-e063-6294a90acff9	2025-02-28	Warnings	Exact identifier application number: M012
Menthol Cough Drops Creamy Strawberry Flavor	MENTHOL AND PECTIN	7-ELEVEN	2f3c3c65-4178-6304-e063-6294a90a51fa	2025-02-28	Warnings	Exact identifier application number: M012
Menthol Cough Drops Creamy Strawberry Flavor	MENTHOL AND PECTIN	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	2efbffd7-bbdd-c5f5-e063-6294a90a15f0	2025-02-25	Warnings	Exact identifier application number: M012
Menthol Cough Drops Honey Vanilla Flavor	MENTHOL	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	2efc46c9-a421-1998-e063-6394a90aeb64	2025-02-25	Warnings	Exact identifier application number: M012
Redicare Cough Drops Cherry Flavored	CHERRY FLAVORED MENTHOL COUGH DROPS	Redicare LLC	2efeaafa-ee96-37ee-e063-6394a90a9a4b	2025-02-25	Warnings	Exact identifier application number: M012
Childrens Allergy	DIPHENHYDRAMINE HCL	Genexa Inc.	e880b8d7-61c3-41cc-e053-2995a90aaaeb	2025-02-20	Warnings	Exact identifier application number: M012
Gencare-Nasal Decongestant PE	PHENYLEPHRINE HYDROCHLORIDE	Pioneer Life Sciences, LLC	596ec923-56a0-4b6e-a69c-8d740feb75a2	2025-02-20	Warnings	Exact identifier application number: M012
Tylenol Cold Plus Flu Severe Day and Tylenol Cold Plus Flu Plus Cough Night 2-pack	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Kenvue Brands LLC	77a2dc96-73ee-4ca2-b1fe-406995802606	2025-02-19	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
04JA59TNSJ	PHENYLEPHRINE HYDROCHLORIDE	61-76-7	PHENYLEPHRINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1298348	acetaminophen 325 MG / diphenhydrAMINE HCl 12.5 MG / phenylephrine HCl 5 MG in 15 mL Oral Solution	PSN	f5a66541-1b15-4dfe-91e0-d8d5f8fdc7fb	7
1298348	acetaminophen 21.7 MG/ML / diphenhydramine hydrochloride 0.833 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution	SCD	f5a66541-1b15-4dfe-91e0-d8d5f8fdc7fb	7
1298348	acetaminophen 325 MG / diphenhydramine HCl 12.5 MG / phenylephrine HCl 5 MG per 15 ML Oral Solution	SY	f5a66541-1b15-4dfe-91e0-d8d5f8fdc7fb	7
1298348	acetaminophen 650 MG / diphenhydramine HCl 25 MG / phenylephrine HCl 10 MG per 30 ML Oral Solution	SY	f5a66541-1b15-4dfe-91e0-d8d5f8fdc7fb	7
1298348	APAP 21.7 MG/ML / Diphenhydramine Hydrochloride 0.833 MG/ML / Phenylephrine Hydrochloride 0.333 MG/ML Oral Solution	SY	f5a66541-1b15-4dfe-91e0-d8d5f8fdc7fb	7
1803669	{1 (acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution) / 1 (acetaminophen 21.7 MG/ML / diphenhydramine hydrochloride 0.833 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution) } Pack	GPCK	9736ad4c-8c2e-421f-b023-f91b72d2828b	5
1803669	1 daytime (acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG in 30 mL Oral Solution) / 1 nighttime (acetaminophen 650 MG / diphenhydrAMINE HCl 25 MG / phenylephrine HCl 10 MG in 30 mL Oral Solution) Pack	PSN	9736ad4c-8c2e-421f-b023-f91b72d2828b	5
1113705	acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG in 15 mL Oral Solution	PSN	9736ad4c-8c2e-421f-b023-f91b72d2828b	5
1298348	acetaminophen 325 MG / diphenhydrAMINE HCl 12.5 MG / phenylephrine HCl 5 MG in 15 mL Oral Solution	PSN	9736ad4c-8c2e-421f-b023-f91b72d2828b	5
1113705	acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution	SCD	9736ad4c-8c2e-421f-b023-f91b72d2828b	5
1298348	acetaminophen 21.7 MG/ML / diphenhydramine hydrochloride 0.833 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution	SCD	9736ad4c-8c2e-421f-b023-f91b72d2828b	5
1803669	1 daytime (acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG per 30 ML Oral Solution) / 1 nighttime (acetaminophen 650 MG / diphenhydramine HCl 25 MG / phenylephrine HCl 10 MG per 30 ML Oral Solution) Pack	SY	9736ad4c-8c2e-421f-b023-f91b72d2828b	5
1113705	acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG per 15 ML Oral Solution	SY	9736ad4c-8c2e-421f-b023-f91b72d2828b	5
1298348	acetaminophen 325 MG / diphenhydramine HCl 12.5 MG / phenylephrine HCl 5 MG per 15 ML Oral Solution	SY	9736ad4c-8c2e-421f-b023-f91b72d2828b	5
1113705	acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG per 30 ML Oral Solution	SY	9736ad4c-8c2e-421f-b023-f91b72d2828b	5
1298348	acetaminophen 650 MG / diphenhydramine HCl 25 MG / phenylephrine HCl 10 MG per 30 ML Oral Solution	SY	9736ad4c-8c2e-421f-b023-f91b72d2828b	5
1113705	APAP 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution	SY	9736ad4c-8c2e-421f-b023-f91b72d2828b	5
1298348	APAP 21.7 MG/ML / Diphenhydramine Hydrochloride 0.833 MG/ML / Phenylephrine Hydrochloride 0.333 MG/ML Oral Solution	SY	9736ad4c-8c2e-421f-b023-f91b72d2828b	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0067-8129-08	00067812908	245.5 mL in 1 BOTTLE (0067-8129-08)	245.5 ml	2015-07-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Drug Facts	Haleon US Holdings LLC	2024-04-10	HUMAN OTC DRUG LABEL	5
Drug Facts	Haleon US Holdings LLC	2024-03-07	HUMAN OTC DRUG LABEL	7