FDA.reportPublic FDA data

Foster and Thrive Caldyphen

Product NDC
70677-1198
11-digit product format
706771198
Labeler code
70677
Product ID
70677-1198_29945218-aa80-7a4e-e063-6394a90acf67
Type
HUMAN OTC DRUG
Nonproprietary name
Calamine and Pramoxine Hydrochloride
Dosage form
LOTION
Route
TOPICAL
Labeler
Strategic Sourcing Services, LLC
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-12-18
Substance
PRAMOXINE HYDROCHLORIDE; ZINC OXIDE
Active strength
10; 80 mg/mL; 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
Foster and Thrive Caldyphen
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PRAMOXINE HYDROCHLORIDE10 mg/mL
ZINC OXIDE80 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii88AYB867L5, SOI2LOH54Z
Rxcui1234532

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
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
70677-1198-1Foster and Thrive Caldyphen177 mL in 1 BOTTLE, PLASTICLOTION1771

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70677-1198-1ML - Milliliter70677-1198f231b169-e17a-4171-816b-c594b4c9b8c112025-01-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70677-1198FOSTER AND THRIVE CALDYPHEN (CALAMINE AND PRAMOXINE HYDROCHLORIDE) LOTION [STRATEGIC SOURCING SERVICES, LLC]1Current NDC, 1 package rows20241220_29945734-4ea6-b702-e063-6294a90ae6f2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1234532calamine 8 % / pramoxine HCl 1 % Topical LotionPSN29945734-4ea6-b702-e063-6294a90ae6f21
1234532calamine 80 MG/ML / pramoxine hydrochloride 10 MG/ML Topical LotionSCD29945734-4ea6-b702-e063-6294a90ae6f21
1234532calamine 8 % / pramoxine hydrochloride 1 % Topical LotionSY29945734-4ea6-b702-e063-6294a90ae6f21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70677-1198-170677119801177 mL in 1 BOTTLE, PLASTIC (70677-1198-1) 177 ml2024-12-18NoNoHistorical