Home NDC 55319-824 Family Wellness Hot and Cold Pain Relief
Product NDC 55319-824
11-digit product format 553190824
Labeler code 55319
Product ID 55319-824_a2424e67-1a45-4f31-b79c-160fd06e8bb2
Type HUMAN OTC DRUG
Nonproprietary name Hot and Cold Pain Relief
Dosage form CREAM
Route TOPICAL
Labeler FAMILY DOLLAR (Family Wellness)
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-09-30
Substance MENTHOL, UNSPECIFIED FORM; METHYL SALICYLATE
Active strength 100; 300 mg/g; mg/g
NDC exclude flag No
Listing certified through 2026-12-31
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 Family Wellness Hot and Cold Pain Relief
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MENTHOL, UNSPECIFIED FORM 100 mg/g METHYL SALICYLATE 300 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination L7T10EIP3A Internal UNII lookup LAV5U5022Y Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 311500 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 55319-824-35 Family Wellness Hot and Cold Pain Relief 35.4 g in 1 TUBE CREAM 35.4 3 55319-824-35 Family Wellness Hot and Cold Pain Relief 1 in 1 CARTON CREAM 1 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55319-824 FAMILY WELLNESS HOT AND COLD PAIN RELIEF (HOT AND COLD PAIN RELIEF) CREAM [FAMILY DOLLAR (FAMILY WELLNESS)] 3 Current NDC, 2 package rows 20241122_b70e343b-18aa-4e45-ae8e-79d8c84ad205.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 18 of 153 · 3,057 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 55319-824-35 55319082435 1 TUBE in 1 CARTON (55319-824-35) / 35.4 g in 1 TUBE 1 tube 2023-09-30 No No Current