HCS Roll-on Antiperspirant

Product NDC
83506-004
Requested package NDC
83506-004-01
11-digit product format
835060004
Labeler code
83506
Product ID
83506-004_eca9326d-1332-4630-aadb-94a2b9d38771
Type
HUMAN OTC DRUG
Nonproprietary name
Aluminum Chlorohydrate
Dosage form
LIQUID
Route
TOPICAL
Labeler
Concordance Healthcare Solutions, LLC.
Application
MO19
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-06-06
Substance
ALUMINUM CHLOROHYDRATE
Active strength
45 mg/mL
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 · 1 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage83506-00483506-004-01IInactivated by FDAexcluded / ndc_excluded.zip367a005e9d99…383a685ebd0f…

Additional Listing Data#

Finished product
Yes
Brand name base
HCS Roll-on Antiperspirant
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALUMINUM CHLOROHYDRATE45 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
HPN8MZW13MInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
77ad372b-5ade-43d2-b1a9-beeb7cdec90bAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
83506-004-012024-11-04C16284748780-11e7a6dab-180e-a2ce-e063-dadaa90aadf7Drug Facts
83506-004-012024-07-30C16284748780-11e7a6dab-180e-a2ce-e063-dadaa90aadf7Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83506-004-01HCS Roll-on Antiperspirant44 mL in 1 BOTTLE, DISPENSINGLIQUID443

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83506-004HCS ROLL-ON ANTIPERSPIRANT (ALUMINUM CHLOROHYDRATE) LIQUID [CONCORDANCE HEALTHCARE SOLUTIONS, LLC.]2Current NDC, 1 package rows20241105_77ad372b-5ade-43d2-b1a9-beeb7cdec90b.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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HCS Roll-on AntiperspirantALUMINUM CHLOROHYDRATEConcordance Healthcare Solutions, LLC.77ad372b-5ade-43d2-b1a9-beeb7cdec90b2026-01-12WarningsExact identifier
application number: MO19
ndc (package): 83506-004-01
ndc (product): 83506-004
ndc11 (package): 83506000401

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83506-004-018350600040144 mL in 1 BOTTLE, DISPENSING (83506-004-01) 44 ml2023-06-06NoNoCurrent