Home NDC 70677-1197 Foster and Thrive Phenolated Calamine
Product NDC 70677-1197
11-digit product format 706771197
Labeler code 70677
Product ID 70677-1197_298197ce-bc0d-7699-e063-6394a90ad392
Type HUMAN OTC DRUG
Nonproprietary name Calamine and Zinc Oxide and Phenol
Dosage form LOTION
Route TOPICAL
Labeler Strategic Sourcing Services LLC
Application M016
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-12-17
Substance ZINC OXIDE; PHENOL
Active strength 160; 10 mg/mL; mg/mL
Pharmacologic classes Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Foster and Thrive Phenolated Calamine
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 160 mg/mL PHENOL 10 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination SOI2LOH54Z Internal UNII lookup 339NCG44TV Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 991369 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 70677-1197-1 Foster and Thrive Phenolated Calamine 177 mL in 1 BOTTLE, PLASTIC LOTION 177 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70677-1197 FOSTER AND THRIVE PHENOLATED CALAMINE (CALAMINE AND ZINC OXIDE AND PHENOL) LOTION [STRATEGIC SOURCING SERVICES LLC] 1 Current NDC, 1 package rows 20241220_298171e1-2826-d33b-e063-6394a90a875a.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 53 of 68 · 1,357 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 70677-1197-1 70677119701 177 mL in 1 BOTTLE, PLASTIC (70677-1197-1) 177 ml 2024-12-17 No No Current