Nasal Decongestant PE

Product NDC: 21130-453
11-digit product format: 211300453
Labeler code: 21130
Product ID: 21130-453_9fc2ece9-cf33-429f-938e-1e96d1cbdb54
Type: HUMAN OTC DRUG
Nonproprietary name: Phenylephrine HCl
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Better Living Brands, LLC
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2005-01-14
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: 2027-12-31
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	21130-453	21130-453-44	D	Discontinued by firm		2026-10-21

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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: Nasal Decongestant PE
Listing expiration: 2027-12-31

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
0153294d-7f52-4d92-8db8-daeca3e29a3b	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
cb89b86a-369e-4204-8910-ae797c503af3	Product name	1	20230706
b5abe2e3-39a1-43eb-9bff-f3c1653fe3df	Product name	2	20190930
d4880ace-a516-8c47-8dfd-73a4ba5887d7	Product name	2	20180830
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814	Product name	3	20150910
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
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	SPL version
21130-453-07	Nasal Decongestant PE	18 in 1 BLISTER PACK	TABLET, FILM COATED	18	21
21130-453-07	Nasal Decongestant PE	2 in 1 CARTON	TABLET, FILM COATED	2	21
21130-453-44	Nasal Decongestant PE	1 in 1 CARTON	TABLET, FILM COATED	1	21
21130-453-44	Nasal Decongestant PE	18 in 1 BLISTER PACK	TABLET, FILM COATED	18	21

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PHENYLEPHRINE HYDROCHLORIDE	ACTIVE INGREDIENT	04JA59TNSJ	NASAL DECONGESTANT PE (PHENYLEPHRINE HCL) TABLET, FILM COATED [BETTER LIVING BRANDS, LLC]	7
PHENYLEPHRINE	ACTIVE MOIETY	1WS297W6MV	NASAL DECONGESTANT PE (PHENYLEPHRINE HCL) TABLET, FILM COATED [BETTER LIVING BRANDS, LLC]	7
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE	INACTIVE INGREDIENT	O7TSZ97GEP	NASAL DECONGESTANT PE (PHENYLEPHRINE HCL) TABLET, FILM COATED [BETTER LIVING BRANDS, LLC]	7
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	NASAL DECONGESTANT PE (PHENYLEPHRINE HCL) TABLET, FILM COATED [BETTER LIVING BRANDS, LLC]	7
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	NASAL DECONGESTANT PE (PHENYLEPHRINE HCL) TABLET, FILM COATED [BETTER LIVING BRANDS, LLC]	7
DEXTROSE MONOHYDRATE	INACTIVE INGREDIENT	LX22YL083G	NASAL DECONGESTANT PE (PHENYLEPHRINE HCL) TABLET, FILM COATED [BETTER LIVING BRANDS, LLC]	7
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	NASAL DECONGESTANT PE (PHENYLEPHRINE HCL) TABLET, FILM COATED [BETTER LIVING BRANDS, LLC]	7
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	NASAL DECONGESTANT PE (PHENYLEPHRINE HCL) TABLET, FILM COATED [BETTER LIVING BRANDS, LLC]	7
MALTODEXTRIN	INACTIVE INGREDIENT	7CVR7L4A2D	NASAL DECONGESTANT PE (PHENYLEPHRINE HCL) TABLET, FILM COATED [BETTER LIVING BRANDS, LLC]	7
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	NASAL DECONGESTANT PE (PHENYLEPHRINE HCL) TABLET, FILM COATED [BETTER LIVING BRANDS, LLC]	7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
21130-453	NASAL DECONGESTANT PE (PHENYLEPHRINE HCL) TABLET, FILM COATED [BETTER LIVING BRANDS, LLC]	20	Current NDC, Legacy NDC, 4 package rows	20250322_0153294d-7f52-4d92-8db8-daeca3e29a3b.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 99 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Freegells Cough Drops Menthol Honey Lemon 80ct	MENTHOL	R.L. ALBERT & SON, INC	61deea94-d0a9-4563-926b-53f255a7c425	2025-10-08	Warnings	Exact identifier application number: M012
FREEGELLS COUGH DROPS MENTHOL STRAWBERRY 30 DROPS	MENTHOL	R.L. ALBERT & SON, INC	c6b36350-386b-4346-bef0-a37ec11319c0	2025-10-08	Warnings	Exact identifier application number: M012
Pain Reliever PM Extra Strength	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	Strategic Sourcing Services LLC	3314b174-d5bb-4843-9288-9b9c5fce79d5	2025-10-08	Warnings	Exact identifier application number: M012
OneSsip Diphenhydramine HCl 12.5 mg/ 5 mL Oral Solution	DIPHENHYDRAMINE HCL	MEDWISE LIFESCIENCES INC.	407b7cbb-7ebd-7b7e-e063-6394a90af501	2025-10-06	Warnings	Exact identifier application number: M012
Quality Choice Medicated Chest Rub	CAMPHOR, MENTHOL, EUCALYPTUS OIL	Quality Choice (CHAIN DRUG MARKETING ASSOCIATION)	d0cce0a0-a6bc-4c45-b9c6-08865b61c1dc	2025-10-06	Warnings	Exact identifier application number: M012
Halls Sugar Free Honey Lemon	MENTHOL	Mondelez Global LLC	2b19fdd2-8088-47f2-be20-f220a6b825fc	2025-10-06	Warnings	Exact identifier application number: M012
Giltuss Childrens Cough and Chest Congestion	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Dextrum Laboratories, Inc	40802fb6-c1ec-d7b0-e063-6394a90ab423	2025-10-06	Warnings	Exact identifier application number: M012
Giltuss Diabetic	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Dextrum Laboratories, Inc	3f64c81a-bbfc-4575-e063-6294a90a6ed7	2025-10-06	Warnings	Exact identifier application number: M012
TexaClear Severe Cough, Cold and Flu	CHOLINE SALICYLATE, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	GM Pharmaceuticals, INC	cb99e5b3-1908-43c9-b31f-d35e7ce58b44	2025-10-06	Warnings	Exact identifier application number: M012
RoboHBr Cough SUPPRESSANT	DEXTROMETHORPHAN HBR	DXM Pharmaceutical, Inc	0af624ce-191f-45e1-882b-e8acb90cc77b	2025-10-06	Warnings	Exact identifier application number: M012
RoboTablets	DEXTROMETHORPHAN	DXM Pharmaceutical, Inc	b92cf698-032d-4d8d-b19c-456c6338b094	2025-10-06	Warnings	Exact identifier application number: M012
SinuLief	LORATADINE	RoseWell Pharmaceuticals LLC	32619143-a782-3497-e063-6394a90aaaec	2025-10-06	Warnings	Exact identifier application number: M012
STAHIST AD	CHLORCYCLIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	Magna Pharmaceuticals, Inc.	ccedbc38-2479-4c35-9f86-a9f29bcfab3f	2025-10-03	Warnings	Exact identifier application number: M012
Childrens PediaClear 8	PYRILAMINE MALEATE	GM Pharmaceuticals, INC	8e524967-d01c-4c93-9198-c42f15fe3fe0	2025-10-03	Warnings	Exact identifier application number: M012
Childrens PediaClear PD	TRIPROLIDINE HYDROCHLORIDE	GM Pharmaceuticals, INC	f3ede5b7-1b0f-493a-b647-4459affc7e54	2025-10-03	Warnings	Exact identifier application number: M012
Guaifenesin and Dextromethorphan Hydrobromide	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	InvaTech Pharma Solutions LLC	40288ecf-043d-eb9e-e063-6394a90ac0a7	2025-10-02	Warnings	Exact identifier application number: M012
Guaifenesin 400	GUAIFENESIN TABLETS 400	InvaTech Pharma Solutions LLC	40291505-55ca-0759-e063-6394a90acee1	2025-10-02		Exact identifier application number: M012
CVS Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	CVS Pharmacy	3dd5b783-5b64-24b5-e063-6394a90ab4ee	2025-10-02	Warnings	Exact identifier application number: M012
Acetaminophen and Diphenhydramine citrate	ACETAMINOPHEN AND DIPHENHYDRAMINE CITRATE	InvaTech Pharma Solutions LLC	403a88fa-e06b-9b6e-e063-6394a90a97b8	2025-10-02	Warnings	Exact identifier application number: M012
Equaline childrens cold and cough	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE	United Natural Foods, Inc. dba UNFI	3053f6d7-0eff-488c-8901-770dcc62af06	2025-10-02	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	0153294d-7f52-4d92-8db8-daeca3e29a3b	21
1049182	phenylephrine hydrochloride 10 MG Oral Tablet	SCD	0153294d-7f52-4d92-8db8-daeca3e29a3b	21

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
21130-453-07	21130045307	2 BLISTER PACK in 1 CARTON (21130-453-07) / 18 TABLET, FILM COATED in 1 BLISTER PACK	2 blister pack	2005-01-14	0000-00-00	No	No	Current
21130-453-44	21130045344	1 in 1 CARTON						Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Signature Select 44-453	Better Living Brands, LLC \| LNK International, Inc.	2026-03-06	HUMAN OTC DRUG LABEL	21