Home NDC 21130-453 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 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.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength 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 Uploaded 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 130 of 178 · 3,551 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join 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 DUAL ACTION CHERRY COUGH SUPPRESSANT ORAL ANESTHETIC MENTHOL Ricola USA Inc. 82813342-2be2-4731-ae90-dbd5eed667a9 2024-12-10 Warnings Exact identifier application number: M012 MOUNTAIN HERB SUGAR FREE WITH STEVIA COUGH SUPPRESSANT ORAL ANESTHETIC MENTHOL Ricola USA Inc. b640a5d2-a7fe-486d-a65f-e7c993f950d6 2024-12-10 Warnings Exact identifier application number: M012 Sugar Free Mountain Herb Cough Suppressant Throat Drops MENTHOL Ricola USA Inc. c3f3c062-55e5-43c1-a016-ee47a7b388a5 2024-12-10 Warnings Exact identifier application number: M012 RICOLA MAX THROAT CARE SWISS CHERRY MENTHOL Ricola USA Inc. ee4733b5-6e5a-438a-97da-110f3ef6c809 2024-12-10 Warnings Exact identifier application number: M012 SUGAR FREE GREEN TEA WITH ECHINACEA COUGH SUPPRESSANT THROAT DROPS MENTHOL Ricola USA Inc. f62fcc38-2d43-40b3-841f-c8eea9ebd1e1 2024-12-10 Warnings Exact identifier application number: M012 DUAL ACTION HONEY LEMON COUGH SUPPRESSANT ORAL ANESTHETIC MENTHOL Ricola USA Inc. 8a6db093-7e52-443f-8dd6-94867606fef8 2024-12-10 Warnings Exact identifier application number: M012 RICOLA MAX THROAT CARE COOL PEPPERMINT MENTHOL Ricola USA Inc. 5885343e-4a6e-44f7-87a4-d52599156197 2024-12-10 Warnings Exact identifier application number: M012 EXTRA STRENGTH WITH NATURAL MENTHOL GLACIER MINT COUGH SUPPRESSANT MENTHOL Ricola USA Inc. 0baf383c-886d-47ca-8a6d-221298c79446 2024-12-10 Warnings Exact identifier application number: M012
DailyMed RxNorm Mappings# 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