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 131 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cold and Flu Nighttime Severe, 24-7 Life	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Lil' Drug Store products, Inc.	05d0410f-164e-e7ee-e063-6394a90a2aaa	2024-12-16	Warnings	Exact identifier application number: M012
tussin dm max daytime nighttime	DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFESESIN	CVS Pharmacy	6feaf29e-de06-4c94-912c-a76ea2cbd8c1	2024-12-16	Warnings	Exact identifier application number: M012
Leader Childrens Multi Symptom Cold	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	CARDINAL HEALTH 110, LLC. DBA LEADER	169ff9cf-fcf5-46a6-b460-259421f2ec07	2024-12-16	Warnings	Exact identifier application number: M012
Childrens Mucus and Cough Relief	DEXTROMETHORPHAN HBR, GUAIFENESIN	CARDINAL HEALTH 110, LLC. DBA LEADER	125eeb3d-0ee2-45bb-81c0-4ca699979886	2024-12-16	Warnings	Exact identifier application number: M012
Dextromethorphan HBr 15 mg Liquid Gels	DEXTROMETHORPHAN HBR	RUGBY LABORATORIES	cf3cc387-6642-43fd-999d-688fdaf65d4f	2024-12-14	Warnings	Exact identifier application number: M012
Allergy Relief Dye-Free Softgel	DIPHENHYDRAMINE HYDROCHLORIDE	CVS PHARMACY, INC	60b1bb79-3ed1-438b-a27f-f7fbc108d114	2024-12-14	Warnings	Exact identifier application number: M012
Rycontuss Cherry Flavor	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Okendpharma, Inc.	c91798fa-48ab-47a0-92da-4d44c2aafde0	2024-12-13	Warnings	Exact identifier application number: M012
Mentholatum Lavender Vaporizing Rub	CAMPHOR, EUCALYPTUS OIL, MENTHOL	The Mentholatum Company	6f208c05-617d-492a-a016-e9d6be3c971f	2024-12-13	Warnings	Exact identifier application number: M012
CVS Vapor Steam	CAMPHOR (SYNTHETIC)	CVS	49da2c40-afc5-5770-e054-00144ff88e88	2024-12-13	Warnings	Exact identifier application number: M012
Kroger Daytime Cold and Flu Softgel	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	The Kroger Company	e428dd83-c538-2a92-e053-2a95a90a0e16	2024-12-13	Warnings	Exact identifier application number: M012
Kroger Nighttime Cold and Flu Softgel	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	The Kroger Company	e46291c7-6f4d-46a2-e053-2a95a90a80a1	2024-12-13	Warnings	Exact identifier application number: M012
Foster and Thrive Childrens Allergy Relief	DIPHENHYDRAMINE HCL	Strategic Sourcing Services LLC	7eaba464-5cdb-4bd4-b272-38fa108658d5	2024-12-13	Warnings	Exact identifier application number: M012
SUDAFED OM Sinus Severe Original	OXYMETAZOLINE HYDROCHLORIDE	Kenvue Brands LLC	1d089074-3969-ce6e-e063-6294a90aa70c	2024-12-12	Warnings	Exact identifier application number: M012
RIGHT REMEDIES Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	Strive Pharmaceuticals Inc	b4fc014c-7c5f-46a4-bf13-57103b6fa018	2024-12-11	Warnings	Exact identifier application number: M012
Diphenhydramine Hydrochloride 25mg	DIPHENHYDRAMINE HYDROCHLORIDE 25MG	Strive Pharmaceuticals Inc	b440eb2e-4de9-2b65-e053-2995a90abda8	2024-12-11	Warnings	Exact identifier application number: M012
Meijer Effervescent Cold Relief	ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE	Meijer Distribution Inc.	6933ca9d-a32d-d856-e053-2a91aa0a408e	2024-12-10	Warnings	Exact identifier application number: M012
Effervescent Orange Cold Relief	ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE	Meijer Distribution Inc.	826b5c0d-7a75-bbf0-e053-2a91aa0aebd6	2024-12-10	Warnings	Exact identifier application number: M012
DUAL ACTION CHERRY COUGH SUPPRESSANT ORAL ANESTHETIC	MENTHOL	Ricola USA Inc.	09141018-37ba-4c93-9051-1ed129c448c1	2024-12-10	Warnings	Exact identifier application number: M012
Original Herb Cough Drops	MENTHOL	Ricola USA Inc.	6ac9d95b-f6b9-4515-b126-697f8f839612	2024-12-10	Warnings	Exact identifier application number: M012
THE ORIGINAL NATURAL HERB COUGH DROPS	MENTHOL	Ricola USA Inc.	989d1529-2875-47bf-81df-65494d62be7a	2024-12-10	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