TopCare Calamine

Product NDC
36800-702
11-digit product format
368000702
Labeler code
36800
Product ID
36800-702_0ccb3ccc-3531-2d08-e063-6394a90ac91a
Type
HUMAN OTC DRUG
Nonproprietary name
calamine 8% and zinc oxide 8% lotion
Dosage form
LOTION
Route
TOPICAL
Labeler
TOPCO ASSOCIATES LLC
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-07-16
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
TopCare 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
36800-702-96TopCare Calamine177 mL in 1 CONTAINERLOTION1775

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-702TOPCARE CALAMINE (CALAMINE 8% AND ZINC OXIDE 8% LOTION) LOTION [TOPCO ASSOCIATES LLC]5Current NDC, Legacy NDC, 1 package rows20231219_8dcf134e-0427-0c43-e053-2995a90a7c26.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617954calamine 8 % / zinc oxide 8 % Topical LotionPSN8dcf134e-0427-0c43-e053-2995a90a7c265
617954calamine 80 MG/ML / zinc oxide 80 MG/ML Topical LotionSCD8dcf134e-0427-0c43-e053-2995a90a7c265
617954calamine 8 % / zinc oxide 8 % Topical LotionSY8dcf134e-0427-0c43-e053-2995a90a7c265
617954Calamine 80 MG/ML / ZNO 80 MG/ML Topical LotionSY8dcf134e-0427-0c43-e053-2995a90a7c265

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-702-9636800070296177 mL in 1 CONTAINER (36800-702-96) 177 ml2019-07-160000-00-00NoNoCurrent