Gencare-Nasal Decongestant PE

Product NDC: 72090-039
11-digit product format: 720900039
Labeler code: 72090
Product ID: 72090-039_b1011774-c13a-48eb-8198-ef443472f5e6
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: 2025-02-18
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
596ec923-56a0-4b6e-a69c-8d740feb75a2	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
351abe41-466c-4dd8-840a-0fdb68318bd5	Product name	1	20230316
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
72090-039-01	Gencare-Nasal Decongestant PE	300 in 1 BOTTLE	TABLET	300		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72090-039	GENCARE-NASAL DECONGESTANT PE (PHENYLEPHRINE HYDROCHLORIDE) TABLET [PIONEER LIFE SCIENCES, LLC]	1	Current NDC, 1 package rows	20250223_596ec923-56a0-4b6e-a69c-8d740feb75a2.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 148 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
COLD MAX	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	DISCOUNT DRUG MART	a1aba467-c91f-4812-b0b9-ff5fdfa298e3	2024-10-17	Warnings	Exact identifier application number: M012
Head Congestion plus Flu Severe PE	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	DISCOUNT DRUG MART	e3dd12f1-dd63-27ae-e053-2995a90aaaeb	2024-10-17	Warnings	Exact identifier application number: M012
COLD and FLU SEVERE	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	DISCOUNT DRUG MART	e44ac549-3e9b-4271-a2b2-ecb124f79832	2024-10-17	Warnings	Exact identifier application number: M012
Mucus Relief Sinus Severe Congestion Relief	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	DISCOUNT DRUG MART	f171a389-8b22-429c-86bc-272156fdc1b7	2024-10-17	Warnings	Exact identifier application number: M012
Daytime Severe Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	DISCOUNT DRUG MART	6c5b5427-e47a-4eff-928a-c891452facf9	2024-10-17	Warnings	Exact identifier application number: M012
COLD AND FLU SEVERE	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	DISCOUNT DRUG MART	ddeb8978-84b6-4a19-b25e-99d1c29e58d9	2024-10-17	Warnings	Exact identifier application number: M012
Mucus Relief Cold and Flu All in One	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	DISCOUNT DRUG MART	b20baef9-6e68-6679-e053-2a95a90a2b63	2024-10-17	Warnings	Exact identifier application number: M012
Mucus Relief Cold Flu and Sore Throat	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	DISCOUNT DRUG MART	b20b71fb-8787-c871-e053-2a95a90a8eb4	2024-10-17	Warnings	Exact identifier application number: M012
Mucus Relief Sinus Pressure Pain and Cough	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	DISCOUNT DRUG MART	b20bc492-fed3-bf05-e053-2a95a90ad393	2024-10-17	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	United Natural Foods, Inc. dba UNFI	a4d6ecb9-ea67-41ed-917b-9bb4d1e50551	2024-10-17	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	United Natural Foods, Inc. dba UNFI	08fda81a-bedd-4ff3-9c32-2066d2cea3f9	2024-10-17	Warnings	Exact identifier application number: M012
Guaifenesin	GUAIFENESIN	American Health Packaging	2fd702ea-3069-472c-b99e-c527f1375705	2024-10-17	Warnings	Exact identifier application number: M012
Mucus Relief Xpect	GUAIFENSIN, DEXTROMETHORPHAN	Selder, S.A. de C.V.	c2b49d10-b60f-3072-e053-2a95a90af004	2024-10-17	Warnings	Exact identifier application number: M012
Head Congestion plus Flu Severe	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	United Natural Foods, Inc. dba UNFI	1db914d3-8bba-405e-9bf9-9b1a5806284c	2024-10-17	Warnings	Exact identifier application number: M012
Cold Medicine XL3	ACETAMINOPHEN CHLORPHENIRAMINE MALEATE PHENYLEPHERINE HYDROCHLORIDE	Selder, S.A. de C.V.	e2c35fae-9dd6-51f2-e053-2995a90a1e9e	2024-10-17	Warnings	Exact identifier application number: M012
Cough and Cold XL3 Xtra	ACETAMINOPHEN CHLORPHENIRAMINE MALEATE DEXTROMETHORPHAN HYDROBROMIDE PHENYLEPHERINE HYDROCHLORIDE	Selder, S.A. de C.V.	da5b31dd-becd-471a-9392-d0ee4b8f9539	2024-10-17	Warnings	Exact identifier application number: M012
Cold Medicine XL3 FORTE	ACETAMINOPHEN CHLORPHENIRAMINE MALEATE PHENYLEPHERINE HYDROCHLORIDE	MIDWAY IMPORTING INC.	58252f15-485c-3061-e053-2a91aa0a2320	2024-10-17	Warnings	Exact identifier application number: M012
Cold Medicine XL3	ACETAMINOPHEN CHLORPHENIRAMINE MALEATE PHENYLEPHERINE HYDROCHLORIDE	Midway Importing, Inc.	e41b9beb-e274-5c02-e053-2995a90ad0f8	2024-10-17	Warnings	Exact identifier application number: M012
Allergy Multi-Symptom	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDE	STRATEGIC SOURCING SERVICES LLC	38e70a28-eff2-4a48-b829-8cd68e80beef	2024-10-17	Warnings	Exact identifier application number: M012
Mucus Relief Xpect	GUAIFENSIN, DEXTROMETHORPHAN	Midway Importing Inc.	c2c8bd26-bbf1-c2e6-e053-2995a90a86a7	2024-10-17	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	596ec923-56a0-4b6e-a69c-8d740feb75a2	1
1049182	phenylephrine hydrochloride 10 MG Oral Tablet	SCD	596ec923-56a0-4b6e-a69c-8d740feb75a2	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
72090-039-01	72090003901	300 TABLET in 1 BOTTLE (72090-039-01)	300 tablet	2025-02-18	No	No	Current