Home NDC 41520-881 CareOne Nasal and Sinus Decongestant
Product NDC 41520-881
11-digit product format 415200881
Labeler code 41520
Product ID 41520-881_76d916fd-fd92-4398-b2c1-ad8c0ffd7a68
Type HUMAN OTC DRUG
Nonproprietary name Pseudoephedrine HCl
Dosage form TABLET, FILM COATED
Route ORAL
Labeler American Sales Company
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2017-09-25
Substance PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength 30 mg/1
Pharmacologic classes Adrenergic alpha-Agonists [MoA], alpha-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 · 11 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…
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 CareOne Nasal and Sinus Decongestant
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 6V9V2RYJ8N Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1049160 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 41520-881-62 CareOne Nasal and Sinus Decongestant 12 in 1 BLISTER PACK TABLET, FILM COATED 12 3 41520-881-62 CareOne Nasal and Sinus Decongestant 2 in 1 CARTON TABLET, FILM COATED 2 3 41520-881-67 CareOne Nasal and Sinus Decongestant 4 in 1 CARTON TABLET, FILM COATED 4 3 41520-881-67 CareOne Nasal and Sinus Decongestant 12 in 1 BLISTER PACK TABLET, FILM COATED 12 3 41520-881-80 CareOne Nasal and Sinus Decongestant 12 in 1 BLISTER PACK TABLET, FILM COATED 12 3 41520-881-80 CareOne Nasal and Sinus Decongestant 8 in 1 CARTON TABLET, FILM COATED 8 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 41520-881 CAREONE NASAL AND SINUS DECONGESTANT (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [AMERICAN SALES COMPANY] 3 Current NDC, Legacy NDC, 6 package rows 20241003_81b31070-9b03-4ce4-8aac-a334544842ae.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 73 of 178 · 3,551 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 41520-881-62 41520088162 2 BLISTER PACK in 1 CARTON (41520-881-62) / 12 TABLET, FILM COATED in 1 BLISTER PACK 2 blister pack 2017-09-25 0000-00-00 No No Current 41520-881-67 41520088167 4 BLISTER PACK in 1 CARTON (41520-881-67) > 12 TABLET, FILM COATED in 1 BLISTER PACK 4 blister pack 2017-09-25 0000-00-00 No No Current 41520-881-80 41520088180 8 BLISTER PACK in 1 CARTON (41520-881-80) / 12 TABLET, FILM COATED in 1 BLISTER PACK 8 blister pack 2017-09-25 0000-00-00 No No Current