TriplePaste Adult Care Rash Treatment

Product NDC
16864-031
11-digit product format
168640031
Labeler code
16864
Product ID
16864-031_4d63cb6f-d54c-bd29-e063-6294a90aa895
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide
Dosage form
PASTE
Route
TOPICAL
Labeler
Advantice Health, LLC
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-05-15
Substance
ZINC OXIDE
Active strength
12.8 g/100g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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
TriplePaste Adult Care Rash Treatment
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE12.8 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SOI2LOH54ZInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
637168Internal RxNorm lookup
729935Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
2cf0575c-8d3d-1f16-e063-6294a90a629dAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16864-031-01TriplePaste Adult Care Rash Treatment227 g in 1 JARPASTE2272

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16864-031TRIPLEPASTE ADULT CARE RASH TREATMENT (ZINC OXIDE) PASTE [ADVANTICE HEALTH, LLC]1Current NDC, 1 package rows20250511_2cf0575c-8d3d-1f16-e063-6294a90a629d.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 17 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Clear Anti-ItchPRAMOXINE HCL, ZINC ACETATEOld East Main Co.91df1434-bce6-4c6e-beee-cb5ec1cc8fff2026-03-02Warnings, Adverse reactionsExact identifier
application number: M016
Advanced HealingPETROLATUMOld East Main Co.cf916191-1de2-4305-b783-9e074c1ad94b2026-03-02Warnings, Adverse reactionsExact identifier
application number: M016
Eczema ReliefCOLLOIDAL OATMEALOld East Main Co.b2dba027-c295-4a41-8d30-144904e1aa342026-03-02Warnings, Adverse reactionsExact identifier
application number: M016
Baby Eczema TherapyCOLLOIDAL OATMEALOld East Main Co.9720e2ad-1bcf-4023-8e92-22a962df3aad2026-03-02Warnings, Adverse reactionsExact identifier
application number: M016
CalamineFERRIC OXIDE REDChain Drug Marketing Association86ff4875-9007-4b7b-8f46-16cbd475d4bb2026-02-27Warnings, Adverse reactionsExact identifier
application number: M016
Clear Anti-ItchPRAMOXINE HCL, ZINC ACETATEChain Drug Marketing Association1ff6bd85-3658-47ea-b6ca-0eb5d8dbb6932026-02-27Warnings, Adverse reactionsExact identifier
application number: M016
CalamineCALAMINE, PRAMOXINE HCLChain Drug Marketing Association6c848b98-f01c-40f2-a9aa-2af76cb370c82026-02-27Warnings, Adverse reactionsExact identifier
application number: M016
Diaper RashZINC OXIDEThe Kroger Co.fcffbe1f-79b8-451a-9384-19533b81d8c82026-02-27Warnings, Adverse reactionsExact identifier
application number: M016
PetroleumWHITE PETROLATUMThe Kroger Co.d2095c7b-61ca-40d3-bbf1-04bed4dd789c2026-02-27Warnings, Adverse reactionsExact identifier
application number: M016
Daily MoisturizingDIMETHICONEThe Kroger Co.ea8b186c-82d5-4552-bcce-03e56023ea992026-02-27Warnings, Adverse reactionsExact identifier
application number: M016
Diaper Rash CreamZINC OXIDESmalls Brand LLC DBA Roe Wellness4bd29285-29b4-5d57-e063-6294a90af4812026-02-27WarningsExact identifier
application number: M016
Vitamin A DLANOLIN, PETROLATUMWalmart Inc.5893801a-25e1-4750-a55b-d9cddd3f12842026-02-27Warnings, Adverse reactionsExact identifier
application number: M016
Diaper RashZINC OXIDEWalmart Inc.320bcbd3-9e91-437f-99c5-066f880a4b322026-02-27Warnings, Adverse reactionsExact identifier
application number: M016
Skin ProtectantPETROLATUMWalmart Inc.eb836922-f467-42ab-a6e7-b787d97e6c172026-02-27Warnings, Adverse reactionsExact identifier
application number: M016
Advanced HealingPETROLATUMWalmart Inc.aa7dbf7f-50be-475b-8140-68be3fa935072026-02-27Warnings, Adverse reactionsExact identifier
application number: M016
White PetrolatumWHITE PETROLATUMWalmart Inc.176d7711-7c4f-4319-91af-0aba1260c4122026-02-27Warnings, Adverse reactionsExact identifier
application number: M016
Soothing MoisturizingCOLLOIDAL OATMEALWalmart Inc.2d813455-c268-4c6d-9952-eaf0e0007d902026-02-27Warnings, Adverse reactionsExact identifier
application number: M016
Rapid Repair Healing CreamALLANTOIN, DIMETHICONEJune Jacobs Labs LLC186c13be-5e41-b9c9-e063-6294a90ad5742026-02-26WarningsExact identifier
application number: M016
LanashieldLANOLINDynarex Corporation94b277dc-6512-4d36-8485-8ea5100974282026-02-26WarningsExact identifier
application number: M016
GLADSKIN ECZEMACT ECZEMACOLLOIDAL OATMEALMicreos North America, Inc.06f9af75-c5ff-d37b-e063-6394a90a4f6c2026-02-25WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
729935TRIPLE PASTE 12.8 % Topical OintmentPSN2cf0575c-8d3d-1f16-e063-6294a90a629d2
637168zinc oxide 12.8 % Topical OintmentPSN2cf0575c-8d3d-1f16-e063-6294a90a629d2
729935zinc oxide 0.128 MG/MG Topical Ointment [Triple Paste]SBD2cf0575c-8d3d-1f16-e063-6294a90a629d2
637168zinc oxide 0.128 MG/MG Topical OintmentSCD2cf0575c-8d3d-1f16-e063-6294a90a629d2
729935Triple Paste 0.128 MG/MG Topical OintmentSY2cf0575c-8d3d-1f16-e063-6294a90a629d2
729935Triple Paste 12.8 % Topical OintmentSY2cf0575c-8d3d-1f16-e063-6294a90a629d2
637168zinc oxide 12.8 % Topical OintmentSY2cf0575c-8d3d-1f16-e063-6294a90a629d2
637168ZNO 0.128 MG/MG Topical OintmentSY2cf0575c-8d3d-1f16-e063-6294a90a629d2
729935ZNO 0.128 MG/MG Topical Ointment [Triple Paste]SY2cf0575c-8d3d-1f16-e063-6294a90a629d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
16864-031-0116864003101227 g in 1 JAR (16864-031-01) 227 g2021-05-15NoNoCurrent