FDA.reportPublic FDA data

Chlorpheniramine Maleate 4 mg

Product NDC
69618-022
Requested package NDC
69618-022-01
11-digit product format
696180022
Labeler code
69618
Product ID
69618-022_cf5edc10-b310-22b0-e053-2995a90a504a
Type
HUMAN OTC DRUG
Nonproprietary name
Chlorpheniramine Maleate
Dosage form
TABLET
Route
ORAL
Labeler
Reliable 1 Laboratories LLC
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2015-11-01
Marketing end
0000-00-00
Substance
CHLORPHENIRAMINE MALEATE
Active strength
4 mg/1
NDC exclude flag
No
Listing certified through
2022-12-31
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 packagepackage69618-02269618-022-01IInactivated by FDA2026-10-05

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 · 9 matching rows.

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

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d17a97fa-387f-690e-d2be-0083ab044a03Product name320170725
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
c6fba691-a132-4ede-95c6-f8c6bd696636Product name120150902
c0200ab5-4954-454e-9676-30b741b245bdProduct name120150730

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
69618-022-012025-01-30Chlorpheniramine Maleate 4 mg
69618-022-102025-01-30Chlorpheniramine Maleate 4 mg
69618-022-012023-03-29Chlorpheniramine Maleate 4 mg
69618-022-102023-03-29Chlorpheniramine Maleate 4 mg
69618-022-012023-01-30Chlorpheniramine Maleate 4 mg
69618-022-102023-01-30Chlorpheniramine Maleate 4 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69618-022-01Chlorpheniramine Maleate 4 mg100 in 1 BOTTLE, PLASTICTABLET1004
69618-022-10Chlorpheniramine Maleate 4 mg1000 in 1 BOTTLE, PLASTICTABLET10004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69618-022-01EA - Each69618-022017f0907-2077-456a-87c8-d7856c70beb512016-05-16
69618-022-10EA - Each69618-0227b7e8781-2215-47be-92d1-6ac20cc04e1812016-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69618-022CHLORPHENIRAMINE MALEATE 4 MG (CHLORPHENIRAMINE MALEATE) TABLET [RELIABLE 1 LABORATORIES LLC]4Legacy NDC, 2 package rows20230331_31dec627-f2e4-6dbe-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1363309chlorpheniramine maleate 4 MG Oral TabletPSN54681242-c861-4415-b5c0-d3ab55b62be18
1363309chlorpheniramine maleate 4 MG Oral TabletSCD54681242-c861-4415-b5c0-d3ab55b62be18
1363309chlorpheniramine maleate 4 MG Oral TabletPSN31dec627-f2e4-6dbe-e054-00144ff8d46c4
1363309chlorpheniramine maleate 4 MG Oral TabletSCD31dec627-f2e4-6dbe-e054-00144ff8d46c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69618-022-0169618002201100 TABLET in 1 BOTTLE, PLASTIC (69618-022-01) 100 tablet2015-11-010000-00-00NoNoCurrent