Calamine

Product NDC
75981-336
11-digit product format
759810336
Labeler code
75981
Product ID
75981-336_4b312a63-f96b-3dcb-e063-6394a90a0815
Type
HUMAN OTC DRUG
Nonproprietary name
Calamine, Pramoxind HCl
Dosage form
LOTION
Route
TOPICAL
Labeler
Perrigo Direct, Inc
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-09-08
Substance
FERRIC OXIDE RED; PRAMOXINE HYDROCHLORIDE
Active strength
80; 10 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
PRAMOXINE HYDROCHLORIDE10 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1K09F3G675, 88AYB867L5
Rxcui1234532

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75981-336-30Calamine177 mL in 1 BOTTLE, PLASTICLOTION1774

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75981-336CALAMINE (CALAMINE, PRAMOXIND HCL) LOTION [PERRIGO DIRECT, INC]2Current NDC, 1 package rows20240607_54a20ec9-ab86-4410-af94-e04393e9d4b3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1234532calamine 8 % / pramoxine HCl 1 % Topical LotionPSN54a20ec9-ab86-4410-af94-e04393e9d4b34
1234532calamine 80 MG/ML / pramoxine hydrochloride 10 MG/ML Topical LotionSCD54a20ec9-ab86-4410-af94-e04393e9d4b34
1234532calamine 8 % / pramoxine hydrochloride 1 % Topical LotionSY54a20ec9-ab86-4410-af94-e04393e9d4b34

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
75981-336-3075981033630177 mL in 1 BOTTLE, PLASTIC (75981-336-30) 177 ml2016-09-08NoNoHistorical