Antiseptic

Product NDC
49035-299
Requested package NDC
49035-299-86
11-digit product format
490350299
Labeler code
49035
Product ID
49035-299_4bd4aa7f-5842-7815-e063-6294a90a2b75
Type
HUMAN OTC DRUG
Nonproprietary name
CETYLPYRIDINIUM CHLORIDE
Dosage form
RINSE
Route
ORAL
Labeler
Walmart Inc.
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2008-02-22
Substance
CETYLPYRIDINIUM CHLORIDE
Active strength
.7 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 · 2 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
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage49035-29949035-299-86IInactivated by FDAexcluded / ndc_excluded.zip86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage49035-29949035-299-86IInactivated by FDAexcluded / ndc_excluded.zipbd6a592717d7…303034d00443…

Additional Listing Data#

Finished product
Yes
Brand name base
Antiseptic
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CETYLPYRIDINIUM CHLORIDE.7 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
D9OM4SK49PInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1100924Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
8916fb44-da82-41d5-941a-293ef1d67dd0Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49035-299-12Antiseptic1500 mL in 1 BOTTLE, PLASTICRINSE150015
49035-299-86Antiseptic1000 mL in 1 BOTTLE, PLASTICRINSE100015

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-299ANTISEPTIC (CETYLPYRIDINIUM CHLORIDE) RINSE [WAL-MART STORES, INC]13Current NDC, Legacy NDC, 2 package rows20240730_8916fb44-da82-41d5-941a-293ef1d67dd0.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
AntisepticCETYLPYRIDINIUM CHLORIDEWalmart Inc.8916fb44-da82-41d5-941a-293ef1d67dd02026-02-27Warnings, Adverse reactionsExact identifier
ndc (package): 49035-299-86
ndc (product): 49035-299
ndc11 (package): 49035029986

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1100924cetylpyridinium chloride 0.07 % Oral RinsePSN8916fb44-da82-41d5-941a-293ef1d67dd015
1100924cetylpyridinium chloride 0.7 MG/ML MouthwashSCD8916fb44-da82-41d5-941a-293ef1d67dd015
1100924cetylpyridinium chloride 0.07 % Oral RinseSY8916fb44-da82-41d5-941a-293ef1d67dd015

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49035-299-86490350299861000 mL in 1 BOTTLE, PLASTIC (49035-299-86) 1000 ml2008-02-220000-00-00NoNoCurrent