Assured Calamine

Product NDC
33992-4130
11-digit product format
339924130
Labeler code
33992
Product ID
33992-4130_0ccb40f9-0734-b059-e063-6394a90aa03c
Type
HUMAN OTC DRUG
Nonproprietary name
Calamine 8% and Zinc Oxide 8%
Dosage form
LOTION
Route
TOPICAL
Labeler
Greenbriar International
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-01-27
Substance
ZINC OXIDE
Active strength
160 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
Assured Calamine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE160 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiSOI2LOH54Z
Rxcui617954

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
33992-4130-6Assured Calamine177 mL in 1 BOTTLE, PLASTICLOTION1773

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33992-4130ASSURED CALAMINE (CALAMINE 8% AND ZINC OXIDE 8%) LOTION [GREENBRIAR INTERNATIONAL]3Current NDC, Legacy NDC, 1 package rows20231219_9d378cc5-9af0-1389-e053-2995a90a0b96.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617954calamine 8 % / zinc oxide 8 % Topical LotionPSN9d378cc5-9af0-1389-e053-2995a90a0b963
617954calamine 80 MG/ML / zinc oxide 80 MG/ML Topical LotionSCD9d378cc5-9af0-1389-e053-2995a90a0b963
617954calamine 8 % / zinc oxide 8 % Topical LotionSY9d378cc5-9af0-1389-e053-2995a90a0b963
617954Calamine 80 MG/ML / ZNO 80 MG/ML Topical LotionSY9d378cc5-9af0-1389-e053-2995a90a0b963

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
33992-4130-633992413006177 mL in 1 BOTTLE, PLASTIC (33992-4130-6) 177 ml2020-01-270000-00-00NoNoCurrent