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 123 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nighttime Cold and Flu	ACETAMINOPHEN, DOXYLAMINE SUCCINATE, DEXTROMETHORPHAN HBR	Health Pharma USA LLC	29bb7822-76c6-e39d-e063-6294a90a64fb	2025-01-07	Warnings	Exact identifier application number: M012
Childrens Allergy Relief	CHILDRENS ALLERGY RELIEF	Allegiant Health	cb6df361-b8e5-4e2f-945f-c20159d76c4f	2025-01-06	Warnings	Exact identifier application number: M012
Nasal Decongestant PE Maximum Strength	PHENYLEPHRINE HCL	WinCo Foods, LLC	bb7a9fed-dc04-4c31-aa7f-4185d955242c	2025-01-06	Warnings	Exact identifier application number: M012
Leader Childrens Cold and Cough	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE	Cardinal Health 110, LLC. dba Leader	207b2677-aaad-4fe4-a96d-963b7dcfba70	2025-01-06	Warnings	Exact identifier application number: M012
Allergy Relief Caplet	DIPHENHYDRAMINE HYDROCHLORIDE	TOPCO ASSOCIATES LLC	126c05e7-2cd9-47d3-96c3-82305714e1db	2025-01-02	Warnings	Exact identifier application number: M012
Right Remedies Adult Long Lasting Cough Relief Softgel	DEXTROMETHORPHAN HYDROBROMIDE	Strive Pharmaceuticals Inc.	e3ea468e-4e12-4dae-b222-8e32456b77b8	2025-01-02	Warnings	Exact identifier application number: M012
AVON HeXashield Congestion Relief Original	OXYMETAZOLINE HYDROCHLORIDE	Tai Guk Pharm. Co., Ltd.	8f2c152c-c564-0cba-e053-2a95a90ab3c7	2025-01-01	Warnings	Exact identifier application number: M012
Multi-Symptom Nighttime Cold and Flu Relief	ACETAMINOPHEN, DOXYLAMINE SUCCINATE, DEXTROMETHORPHAN HBR	Advanced Rx LLC	a75553bd-f3f0-47bd-b3c3-aeeb0d1a81b4	2025-01-01	Warnings	Exact identifier application number: M012
Cough Relief	DEXTROMETHORPHAN HYDROBROMIDE	Advanced Rx LLC	297e10e3-e740-4434-91a2-2e5c54985d33	2025-01-01	Warnings	Exact identifier application number: M012
MUCUS RELIEF DM	GUAIFENESIN, DEXTROMETHORPHAN HBR	Advanced Rx LLC	64620186-a45b-4c35-a3b9-a347348f93f7	2025-01-01	Warnings	Exact identifier application number: M012
DM Max	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Best Choice	57a44bbf-a304-47b9-8adc-4442c7787853	2025-01-01	Warnings	Exact identifier application number: M012
Long Acting Cough Softgels	DEXTROMETHORPHAN HYDROBROMIDE	CVS PHARMACY, INC	322daee6-c61d-43d3-a54d-a354fd3df242	2025-01-01	Warnings	Exact identifier application number: M012
Adult Tussin DM Lil Drug Store Products	DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN	Lil' Drug Store Products, Inc	1915cf2a-ebaa-4c47-8991-5b741fa01be2	2024-12-31	Warnings	Exact identifier application number: M012
Congestion Relief Lil Drug Store Products	OXYMETAZOLINE HYDROCHLORIDE	Lil' Drug Store Products, Inc	8fca348c-ecb6-4a91-89dd-8bd4c05ac745	2024-12-31	Warnings	Exact identifier application number: M012
DAYTIME COLD AND FLU MULTI SYMPTOM	DAYTIME COLD AND FLU MULTI SYMPTOM	TARGET CORP	9dea350d-2f09-b944-e053-2995a90a2b63	2024-12-30	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	Walgreens	2b7aa3f5-3bc9-471f-8ff7-3c52719f0acb	2024-12-30	Warnings	Exact identifier application number: M012
Pediacare Childrens Cough and Cold Grape	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	RANDOB LABS,LTD. DBA CROSSINGWELL CONSUMER HEALTH	fabafdc1-9dd8-4258-af49-bab1e29ad109	2024-12-30	Warnings	Exact identifier application number: M012
Pediacare Childrens Cough and Congestion Grape	DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN	RANDOB LABS,LTD. DBA CROSSINGWELL CONSUMER HEALTH	9576723b-748c-45e7-bc0d-cc109b9f6735	2024-12-30	Warnings	Exact identifier application number: M012
Cold and Flu Nighttime Severe	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Lil' Drug Store Products, Inc.	ef6836fa-d104-d7b3-e053-2a95a90af2b8	2024-12-30	Warnings	Exact identifier application number: M012
Circle K Congestion Relief	OXYMETAZOLINE HYDROCHLORIDE	Lil' Drug Store Products, Inc	7e02fe57-f42f-4d3c-9002-4c4c0b1fafd6	2024-12-30	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