Calamine

Product NDC
36800-063
11-digit product format
368000063
Labeler code
36800
Product ID
36800-063_4ab7ad96-87b5-6284-e063-6294a90ae847
Type
HUMAN OTC DRUG
Nonproprietary name
FERRIC OXIDE RED
Dosage form
LOTION
Route
TOPICAL
Labeler
Topco Associates LLC
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1991-09-15
Substance
FERRIC OXIDE RED; ZINC OXIDE
Active strength
80; 80 mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FERRIC OXIDE RED80 mg/mL
ZINC OXIDE80 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1K09F3G675, SOI2LOH54Z
Rxcui617954

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-063-26Calamine237 mL in 1 BOTTLE, PLASTICLOTION23722
36800-063-30Calamine177 mL in 1 BOTTLE, PLASTICLOTION17722
36800-063-34Calamine237 mL in 1 BOTTLE, PLASTICLOTION23722

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
36800-063-30ML - Milliliter36800-063ba0277e0-25f2-46b1-b6ce-22e95cb90c9712020-08-06

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-063CALAMINE (FERRIC OXIDE RED) LOTION [TOPCO ASSOCIATES LLC]21Current NDC, Legacy NDC, 3 package rows20250416_2b32e720-ac71-4d60-bc06-e28a00f8a450.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617954calamine 8 % / zinc oxide 8 % Topical LotionPSN2b32e720-ac71-4d60-bc06-e28a00f8a45022
617954calamine 80 MG/ML / zinc oxide 80 MG/ML Topical LotionSCD2b32e720-ac71-4d60-bc06-e28a00f8a45022
617954calamine 8 % / zinc oxide 8 % Topical LotionSY2b32e720-ac71-4d60-bc06-e28a00f8a45022
617954Calamine 80 MG/ML / ZNO 80 MG/ML Topical LotionSY2b32e720-ac71-4d60-bc06-e28a00f8a45022

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-063-2636800006326237 mL in 1 BOTTLE, PLASTIC (36800-063-26) 237 ml1991-09-150000-00-00NoNoCurrent
36800-063-3036800006330177 mL in 1 BOTTLE, PLASTIC (36800-063-30) 177 ml1991-09-150000-00-00NoNoCurrent
36800-063-3436800006334237 mL in 1 BOTTLE, PLASTIC (36800-063-34) 237 ml1991-09-150000-00-00NoNoCurrent