Sinus Relief

Product NDC: 21130-502
11-digit product format: 211300502
Labeler code: 21130
Product ID: 21130-502_c768e454-e3ef-4937-ab71-b89b077c60d3
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen, Phenylephrine HCl
Dosage form: TABLET
Route: ORAL
Labeler: Better Living Brands, LLC
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2005-06-23
Substance: ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE
Active strength: 325; 5 mg/1; mg/1
Pharmacologic classes: Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
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: Sinus Relief
Brand name suffix: MAXIMUM STRENGTH
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ACETAMINOPHEN	325 mg/1
PHENYLEPHRINE HYDROCHLORIDE	5 mg/1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
21130-502-21	Sinus ReliefMAXIMUM STRENGTH	2 in 1 CARTON	TABLET	2		16
21130-502-21	Sinus ReliefMAXIMUM STRENGTH	12 in 1 BLISTER PACK	TABLET	12		16

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	SINUS RELIEF MAXIMUM STRENGTH (ACETAMINOPHEN, PHENYLEPHRINE HCL) TABLET [BETTER LIVING BRANDS, LLC]	2
PHENYLEPHRINE HYDROCHLORIDE	ACTIVE INGREDIENT	04JA59TNSJ	SINUS RELIEF MAXIMUM STRENGTH (ACETAMINOPHEN, PHENYLEPHRINE HCL) TABLET [BETTER LIVING BRANDS, LLC]	2
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	SINUS RELIEF MAXIMUM STRENGTH (ACETAMINOPHEN, PHENYLEPHRINE HCL) TABLET [BETTER LIVING BRANDS, LLC]	2
PHENYLEPHRINE	ACTIVE MOIETY	1WS297W6MV	SINUS RELIEF MAXIMUM STRENGTH (ACETAMINOPHEN, PHENYLEPHRINE HCL) TABLET [BETTER LIVING BRANDS, LLC]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SINUS RELIEF MAXIMUM STRENGTH (ACETAMINOPHEN, PHENYLEPHRINE HCL) TABLET [BETTER LIVING BRANDS, LLC]	2
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	SINUS RELIEF MAXIMUM STRENGTH (ACETAMINOPHEN, PHENYLEPHRINE HCL) TABLET [BETTER LIVING BRANDS, LLC]	2
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	SINUS RELIEF MAXIMUM STRENGTH (ACETAMINOPHEN, PHENYLEPHRINE HCL) TABLET [BETTER LIVING BRANDS, LLC]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SINUS RELIEF MAXIMUM STRENGTH (ACETAMINOPHEN, PHENYLEPHRINE HCL) TABLET [BETTER LIVING BRANDS, LLC]	2
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	SINUS RELIEF MAXIMUM STRENGTH (ACETAMINOPHEN, PHENYLEPHRINE HCL) TABLET [BETTER LIVING BRANDS, LLC]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	SINUS RELIEF MAXIMUM STRENGTH (ACETAMINOPHEN, PHENYLEPHRINE HCL) TABLET [BETTER LIVING BRANDS, LLC]	2
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	SINUS RELIEF MAXIMUM STRENGTH (ACETAMINOPHEN, PHENYLEPHRINE HCL) TABLET [BETTER LIVING BRANDS, LLC]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
21130-502	SINUS RELIEF MAXIMUM STRENGTH (ACETAMINOPHEN, PHENYLEPHRINE HCL) TABLET [BETTER LIVING BRANDS, LLC]	15	Current NDC, Legacy NDC, 2 package rows	20241105_ccd30132-6e29-48a2-a380-7c14984fc723.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 102 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
AXIV NightTime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	VIVUNT PHARMA LLC	131f6314-c9a1-7af3-e063-6294a90abe6f	2025-09-17	Warnings	Exact identifier application number: M012
AXIV DayTime - NightTime 48 Softgels	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	VIVUNT PHARMA LLC	1320e243-344f-98ed-e063-6294a90a0092	2025-09-17	Warnings	Exact identifier application number: M012
AXIV Sinus Severe Mucus	ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HYDROCLORIDE	VIVUNT PHARMA LLC	13245298-8b78-e177-e063-6294a90a6bec	2025-09-17	Warnings	Exact identifier application number: M012
GoodSense Tussin CF Multi-Symptom Cold, Raspberry	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Geiss, Destin & Dunn Inc.	3f05cf84-d485-7688-e063-6394a90ae740	2025-09-17	Warnings	Exact identifier application number: M012
Daytime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Family Dollar (FAMILY WELLNESS)	5d7466b4-fdb7-432b-880d-e7aa4a4acbda	2025-09-17	Warnings	Exact identifier application number: M012
allergy relief Childrens	DIPHENHYDRAMINE HCL	United Natural Foods, Inc. dba UNFI	e34d8bf5-e12e-453c-93ea-9c7988c4f13d	2025-09-16	Warnings	Exact identifier application number: M012
DayTime Cold Flu Non Drowsy	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Harris Teeter, LLC	67beb9f6-4e0a-4f7b-b50a-4bcd3a01354f	2025-09-16	Warnings	Exact identifier application number: M012
DOMETUSS	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	Domel Laboratories	3ebfc62f-27f6-48b2-9bae-bdefbd1d05fe	2025-09-16	Warnings	Exact identifier application number: M012
CareOne Severe Congestion Nasal	OXYMETAZOLINE HYDROCHLORIDE	American Sales Company	d1dba68b-c4e1-4afc-9aee-6a51341b89f5	2025-09-16	Warnings	Exact identifier application number: M012
Daytime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	FSA Store Inc. (Caring Mills)	e69ef8dc-09d2-46de-aebf-ba735f4cc7ea	2025-09-16	Warnings	Exact identifier application number: M012
Menthol Cough Drops Honey Lemon Flavor	MENTHOL HONEY LEMON FLAVOR	CVS Pharmacy	3ea9a1f2-75b3-c67a-e063-6294a90a8caf	2025-09-13	Warnings	Exact identifier application number: M012
Menthol Cough Drops Honey Lemon Flavor	MENTHOL HONEY LEMON FLAVOR	CVS Pharmacy	3eab4cf9-6fdc-a6fb-e063-6394a90a8633	2025-09-13	Warnings	Exact identifier application number: M012
COLD AND FLU DAYTIME-NIGHTTIME	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	TARGET CORP	9de9fab3-890a-158d-e053-2a95a90af423	2025-09-13	Warnings	Exact identifier application number: M012
Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	Precision Dose, Inc.	4d0f4f5b-3135-4457-bb8f-ad9d28ca5ea4	2025-09-12	Warnings	Exact identifier application number: M012
Nasal Spray, Circle K	OXYMETAZOLINE HYDROCHLORIDE 0.05% SOLUTION	Lil' Drug Store Products, Inc.	3ea06e88-a2c6-621b-e063-6294a90a1075	2025-09-12	Warnings	Exact identifier application number: M012
Daytime Nighttime Cold Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Harris Teeter, LLC	a0090dc6-0fe5-4ab2-a2cf-6ed19892f363	2025-09-12	Warnings	Exact identifier application number: M012
Multi Symptom Cold and Multi Symptom Nighttime Cold Childrens	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI, ACETAMINOPHEN, DIPHENHYDRAMINE HCI, PHENYLEPHRINE HCI	CVS Pharmacy	ebf2dbb4-96fa-4bf6-9afd-8aa8b5369f2e	2025-09-12	Warnings	Exact identifier application number: M012
Daytime Nighttime Cold Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	FSA Store Inc. (Caring Mills)	8d7bb31b-a47d-4252-a0a7-79d286179fb9	2025-09-12	Warnings	Exact identifier application number: M012
Daytime Nighttime Cold Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Family Dollar (FAMILY WELLNESS)	150e5c3a-7c86-4b66-af30-a376df697401	2025-09-12	Warnings	Exact identifier application number: M012
SEVERE COUGH COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	67f8d405-a2ad-4ade-93b4-9b09a0d81d8e	2025-09-11	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
04JA59TNSJ	PHENYLEPHRINE HYDROCHLORIDE	61-76-7	PHENYLEPHRINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1046378	acetaminophen 325 MG / phenylephrine HCl 5 MG Oral Tablet	PSN	ccd30132-6e29-48a2-a380-7c14984fc723	16
1046378	acetaminophen 325 MG / phenylephrine hydrochloride 5 MG Oral Tablet	SCD	ccd30132-6e29-48a2-a380-7c14984fc723	16
1046378	APAP 325 MG / phenylephrine hydrochloride 5 MG Oral Tablet	SY	ccd30132-6e29-48a2-a380-7c14984fc723	16

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
21130-502-21	21130050221	2 BLISTER PACK in 1 CARTON (21130-502-21) / 12 TABLET in 1 BLISTER PACK	2 blister pack	2005-06-23	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Signature Select 44-502	Better Living Brands, LLC \| LNK International, Inc.	2026-09-09	HUMAN OTC DRUG LABEL	17