Decongestant PE

Product NDC: 69168-271
11-digit product format: 691680271
Labeler code: 69168
Product ID: 69168-271_2b621db5-4138-44f0-9c86-28468ba954af
Type: HUMAN OTC DRUG
Nonproprietary name: Phenylephrine HCl
Dosage form: TABLET
Route: ORAL
Labeler: Allegiant Health
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2014-12-23
Substance: PHENYLEPHRINE HYDROCHLORIDE
Active strength: 5 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: Decongestant PE
Brand name suffix: Non Drowsy
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PHENYLEPHRINE HYDROCHLORIDE	5 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
1299145	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
7a3098b4-381c-4f32-97a7-87b53fd64428	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
69168-271-17	Decongestant PENon Drowsy	300 in 1 BOTTLE	TABLET	300		6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69168-271	DECONGESTANT PE NON DROWSY (PHENYLEPHRINE HCL) TABLET [ALLEGIANT HEALTH]	5	Current NDC, Legacy NDC, 1 package rows	20231114_7a3098b4-381c-4f32-97a7-87b53fd64428.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 39 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cold Multi-Symptom Severe	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Valu Merchandisers Company	b0d9d869-9f0d-4834-aa2b-1ee21fd8b67b	2026-04-16	Warnings	Exact identifier application number: M012
Rompe Pecho Max	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN	Efficient Laboratories Inc	4f86985c-48f3-2148-e063-6394a90ae2f1	2026-04-15	Warnings	Exact identifier application number: M012
Childrens Daytime Mucus	DEXTROMETHORPHAN HBR	Walgreens	7a55b7e1-1054-421e-847e-5e4d90d1aebb	2026-04-15	Warnings	Exact identifier application number: M012
Childrens Nighttime Mucus	DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATE	Walgreens	dc69f581-27c7-4030-bb18-39685c7691a1	2026-04-15	Warnings	Exact identifier application number: M012
Pseudoephedrine HCl	PSEUDOEPHEDRINE HCL	Major Pharmaceuticals	da95c643-7122-4025-977f-42205080e56b	2026-04-15	Warnings	Exact identifier application number: M012
Daytime Nighttime Chewable	DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATE	Walgreens	9ddc0aa7-e7b8-41c5-a2b4-fece0c2e26c6	2026-04-15	Warnings	Exact identifier application number: M012
foster and thrive nasal	OXYMETAZOLINE HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	4f7090f4-89c9-c3da-e063-6294a90a4716	2026-04-14	Warnings	Exact identifier application number: M012
Sinus and Headache	ACETAMINOPHEN, PHENYLEPHRINE HCL	Walgreen Company	2115f095-2d75-4e02-a6af-22dd693e0840	2026-04-14	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	Lidl US LLC	00f89eee-0edc-40dc-9297-8645afb91004	2026-04-14	Warnings	Exact identifier application number: M012
Sinus Pressure and Pain Daytime Nighttime Maximum Strength	ACETAMINOPHEN, DIPHENHYDRAMINE HCL, GUAIFENESIN, PHENYLEPHRINE HCL	Walgreen Company	8647c136-a323-453a-8f57-e66938bbf639	2026-04-14	Warnings	Exact identifier application number: M012
daytime severe cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	5515148f-3e1d-4b03-89fa-40967d508292	2026-04-14	Warnings	Exact identifier application number: M012
Mucus Relief Sinus Severe Congestion and Pain	ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	c70e6506-6c5b-4d3f-ab18-a690840caabc	2026-04-13	Warnings	Exact identifier application number: M012
Nasal Decongestant PE	PHENYLEPHRINE HCL	Walgreen Company	48387b95-8240-4d6e-842b-cc29cc18709c	2026-04-13	Warnings	Exact identifier application number: M012
Sinufrin Plus No Drip Decongestant	NASAL CONGESTION RELIEF	NeilMed Pharmaceuticals Inc	4f06c732-1f9f-bfc6-e063-6394a90a53f5	2026-04-13	Warnings	Exact identifier application number: M012
Severe Sinus Congestion	ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL	Walgreen Company	8745d9d8-640d-4e3b-96fe-d25032c1e3ce	2026-04-13	Warnings	Exact identifier application number: M012
Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	Cardinal Health 107, LLC	5a5c5f33-5b70-465d-a38b-6f518af09788	2026-04-13	Warnings	Exact identifier application number: M012
Allergy	DIPHENHYDRAMINE HCL	Publix Super Markets Inc	f2263e38-f686-45ed-bf85-b47f5e1aa982	2026-04-13	Warnings	Exact identifier application number: M012
Daytime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCL	BETTER LIVING BRANDS, LLC	46adbf94-5b93-ee64-e063-6294a90a1144	2026-04-11	Warnings	Exact identifier application number: M012
good sense night time	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	L. Perrigo Company	0c79357a-b79d-4952-8e6d-ef3d60dde2fa	2026-04-10	Warnings	Exact identifier application number: M012
basic care nighttime cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Amazon.com Services LLC	88d27c25-a305-4398-9590-df10d2504b01	2026-04-09	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
1299145	phenylephrine HCl 5 MG Oral Tablet	PSN	7a3098b4-381c-4f32-97a7-87b53fd64428	6
1299145	phenylephrine hydrochloride 5 MG Oral Tablet	SCD	7a3098b4-381c-4f32-97a7-87b53fd64428	6
1299145	phenylephrine HCl 5 MG Oral Tablet	SY	7a3098b4-381c-4f32-97a7-87b53fd64428	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69168-271-17	69168027117	300 TABLET in 1 BOTTLE (69168-271-17)	300 tablet	2021-06-16	0000-00-00	No	No	Current