MAX BARRIER Skin Protectant

Product NDC
82897-468
11-digit product format
828970468
Labeler code
82897
Product ID
82897-468_1247a3be-bad2-1253-e063-6294a90ad7e8
Type
HUMAN OTC DRUG
Nonproprietary name
ZINC OXIDE
Dosage form
CREAM
Route
TOPICAL
Labeler
GL HEALTH, INC.
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-03-08
Substance
ZINC OXIDE
Active strength
400 mg/mL
Pharmacologic classes
Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
MAX BARRIER Skin Protectant
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE400 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiSOI2LOH54Z
Rxcui1305337

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82897-468-00MAX BARRIER Skin Protectant3.3 mL in 1 PACKETCREAM3.31

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82897-468MAX BARRIER SKIN PROTECTANT (ZINC OXIDE) CREAM [GL HEALTH, INC.]1Current NDC, 1 package rows20240308_5eec834d-d8f3-49e3-b230-f8cf88b795e6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1305337zinc oxide 40 % Topical CreamPSN5eec834d-d8f3-49e3-b230-f8cf88b795e61
1305337zinc oxide 400 MG/ML Topical CreamSCD5eec834d-d8f3-49e3-b230-f8cf88b795e61
1305337zinc oxide 40 % Topical CreamSY5eec834d-d8f3-49e3-b230-f8cf88b795e61
1305337ZNO 400 MG/ML Topical CreamSY5eec834d-d8f3-49e3-b230-f8cf88b795e61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82897-468-00828970468003.3 mL in 1 PACKET (82897-468-00) 3.3 ml2024-03-08NoNoHistorical