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 74 of 180 · 3,583 matching rows.
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