Calamine

Product NDC
68071-4322
11-digit product format
680714322
Labeler code
68071
Product ID
68071-4322_1a3dc619-6b13-21b4-e063-6294a90acb1e
Type
HUMAN OTC DRUG
Nonproprietary name
FERRIC OXIDE RED
Dosage form
LOTION
Route
TOPICAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-01-07
Substance
FERRIC OXIDE RED; ZINC OXIDE
Active strength
8; 8 g/mL; mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Calamine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FERRIC OXIDE RED8 g/mL
ZINC OXIDE8 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1K09F3G675, SOI2LOH54Z
Rxcui617954

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-4322-62023-07-03C16284748780-1ba0f9c33-3aec-a910-e053-dadaa90a0b85Drug Facts
68071-4322-62023-01-30C16284748780-1ba0f9c33-3aec-a910-e053-dadaa90a0b85Drug Facts
68071-4322-62021-03-02C16284748780-1ba0f9c33-3aec-a910-e053-dadaa90a0b85Drug Facts
68071-4322-62021-01-29C16284748780-1ba0f9c33-3aec-a910-e053-dadaa90a0b85Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-4322-6Calamine177 mL in 1 BOTTLELOTION1775

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-4322CALAMINE (FERRIC OXIDE RED) LOTION [NUCARE PHARMACEUTICALS,INC.]5Current NDC, Legacy NDC, 1 package rows20240706_66e98554-e158-a519-e053-2a91aa0a6783.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617954calamine 8 % / zinc oxide 8 % Topical LotionPSN66e98554-e158-a519-e053-2a91aa0a67835
617954calamine 80 MG/ML / zinc oxide 80 MG/ML Topical LotionSCD66e98554-e158-a519-e053-2a91aa0a67835
617954calamine 8 % / zinc oxide 8 % Topical LotionSY66e98554-e158-a519-e053-2a91aa0a67835
617954Calamine 80 MG/ML / ZNO 80 MG/ML Topical LotionSY66e98554-e158-a519-e053-2a91aa0a67835

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-4322-668071432206177 mL in 1 BOTTLE (68071-4322-6) 177 ml2018-03-080000-00-00NoNoCurrent