nasal decongestant

Product NDC
62011-0312
Requested package NDC
62011-0312-2
11-digit product format
620110312
Labeler code
62011
Product ID
62011-0312_f7ac406f-9cc6-4af2-8402-d1b4abaeea07
Type
HUMAN OTC DRUG
Nonproprietary name
Pseudoephedrine HCl
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Strategic Sourcing Services, LLC (Health Mart)
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
1981-08-25
Marketing end
0000-00-00
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
2024-12-31
Current FDA listing
Historical FDA.report record

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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage62011-031262011-0312-2DDiscontinued by firm2026-10-05

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 · 4 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62011-0312-1EA - Each62011-03122e7b187b-aafd-4667-a699-9504abb404e712017-06-15
62011-0312-2EA - Each62011-0312111fc884-d087-4983-b5a7-326a1f86016c12017-11-06
62011-0312-3EA - Each62011-0312b29fce1b-ca79-495a-9f6c-8d19acccc3ac12017-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62011-0312NASAL DECONGESTANT NON-DROWSY (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [STRATEGIC SOURCING SERVICES, LLC (HEALTH MART)]14Legacy NDC20250411_37d70b85-a519-441d-9b33-784684f55dbc.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62011-0312-2620110312022 BLISTER PACK in 1 CARTON (62011-0312-2) > 24 TABLET, FILM COATED in 1 BLISTER PACK2 blister pack1981-08-250000-00-00NoNoCurrent