Gencare-Nasal Decongestant PE

Product NDC: 72090-025
11-digit product format: 720900025
Labeler code: 72090
Product ID: 72090-025_09cdc2dd-ca13-478a-bc31-03ba9430432b
Type: HUMAN OTC DRUG
Nonproprietary name: PHENYLEPHRINE HYDROCHLORIDE
Dosage form: TABLET
Route: ORAL
Labeler: Pioneer Life Sciences, LLC
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2024-11-07
Substance: PHENYLEPHRINE HYDROCHLORIDE
Active strength: 10 mg/1
Pharmacologic classes: Adrenergic alpha1-Agonists [MoA], 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: Gencare-Nasal Decongestant PE
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PHENYLEPHRINE HYDROCHLORIDE	10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
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
1049182	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
ad4d74a8-a762-4378-9016-f7c83421073e	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
05a8cdd1-eeb8-409e-b938-0778225eca7d	Product name	4	20250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9	Product name	8	20250220
f489e8f3-5c9e-4818-b539-a73587edcfc7	Product name	2	20240229
0f7ae452-206d-4fc4-868d-56fc47074084	Product name	1	20231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3df	Product name	2	20190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814	Product name	3	20150910
42f3c020-f1b3-89bc-7bdc-e1f10e680485	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
72090-025-01	Gencare-Nasal Decongestant PE	300 in 1 BOTTLE	TABLET	300		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72090-025	GENCARE-NASAL DECONGESTANT PE (PHENYLEPHRINE HYDROCHLORIDE) TABLET [PIONEER LIFE SCIENCES, LLC]	1	Current NDC, 1 package rows	20241109_ad4d74a8-a762-4378-9016-f7c83421073e.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 126 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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
SDA Laboratories Tussin	GUAIFENESIN	SDA Laboratories, Inc.	2a444cc8-96be-9432-e063-6394a90a1b63	2024-12-27	Warnings	Exact identifier application number: M012
SDA Laboratories Tussin DM	DEXTROMETHORPHAN HBR, GUAIFENESIN	SDA Laboratories, Inc.	2a445f31-818d-11b1-e063-6294a90a8cb1	2024-12-27	Warnings	Exact identifier application number: M012
Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	Richmond Pharmaceuticals Inc.	f184b2aa-91a4-44f9-b688-d4e318181984	2024-12-26	Warnings	Exact identifier application number: M012
Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	Richmond Pharmaceuticals, Inc.	2792032a-ff0f-4d5f-a8e3-b8b8c54f4e99	2024-12-26	Warnings	Exact identifier application number: M012
OXYMETAZOLINE HYDROCHLORIDE	OXYMETAZOLINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION INC.	c7b1f980-9b0d-4f63-a70d-fd366658f863	2024-12-26	Warnings	Exact identifier application number: M012
OXYMETAZOLINE HYDROCHLORIDE	OXYMETAZOLINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION INC.	2ee2b332-9b85-45a6-b242-3f0ebfbd08a6	2024-12-26	Warnings	Exact identifier application number: M012
OXYMETAZOLINE HYDROCHLORIDE	OXYMETAZOLINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION INC	aebc7cf8-aaf7-4746-89f5-a64d0be1641e	2024-12-26	Warnings	Exact identifier application number: M012
Foster and Thrive Chest Congestion Relief	GUAIFENESIN	Strategic Sourcing Services LLC	a1661a66-5e8c-4144-9c82-cbbcc75fb222	2024-12-23	Warnings	Exact identifier application number: M012
Geri Dryl	DIPHENHYDRAMINE HCL	GERI-CARE PHARMACEUTICALS, CORP	34d36146-6827-4800-8483-c0edb8f4cc28	2024-12-23	Warnings	Exact identifier application number: M012
Guaiasorb DM	DEXTROMETHORPHAN HBR, GUAIFENESIN	Geri-Care Pharmaceuticals, Corp	6299e352-116e-43f2-b40f-c704a7bd5d61	2024-12-23	Warnings	Exact identifier application number: M012
Equaline Chest Congestion Relief	GUAIFENESIN	United Natural Foods, Inc. dba UNFI	ad9fde8b-10cd-4778-917d-1ed6b67e5ab1	2024-12-23	Warnings	Exact identifier application number: M012
Equaline Chest Congestion Relief DM DM	DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN	United Natural Foods, Inc. dba UNFI	a40f5893-eb96-4e0e-b965-d78293c48dc9	2024-12-23	Warnings	Exact identifier application number: M012
Tukol X-Pecto Miel Multi Symptom Cold	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Genomma Lab USA, Inc.	b9d32964-5bd7-44b0-be98-827d5310ed4f	2024-12-20	Warnings	Exact identifier application number: M012
Halls Honey Vanilla	MENTHOL	Mondelez Global LLC	8e94a1b8-8915-4595-b097-8a0a319d54aa	2024-12-20	Warnings	Exact identifier application number: M012
Halls Sugar Free Mentho-Lyptus	MENTHOL	Mondelez Global LLC	96046858-c57b-426e-8279-91b35e05bcdb	2024-12-20	Warnings	Exact identifier application number: M012
Vapor Inhaler levmetamfetamine nasal decongestant, Best Choice	LEVMETAMFETAMINE	Valu Merchandisers Company	3f1c086c-bc22-4abb-9921-565a13f30c20	2024-12-20	Warnings	Exact identifier application number: M012
Vapor Inhaler	LEVMETAMFETAMINE NASAL DECONGESTANT	Walgreens	77924474-ccc7-497b-9168-91490bcfadfc	2024-12-20	Warnings	Exact identifier application number: M012

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
04JA59TNSJ	PHENYLEPHRINE HYDROCHLORIDE	61-76-7	PHENYLEPHRINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1049182	phenylephrine HCl 10 MG Oral Tablet	PSN	ad4d74a8-a762-4378-9016-f7c83421073e	2
1049182	phenylephrine hydrochloride 10 MG Oral Tablet	SCD	ad4d74a8-a762-4378-9016-f7c83421073e	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
72090-025-01	72090002501	300 TABLET in 1 BOTTLE (72090-025-01)	300 tablet	2024-11-07	No	No	Current