Home NDC 79804-618-03 Healthy Back Institute Rub On Relief
Product NDC 79804-618
Requested package NDC 79804-618-03
11-digit product format 798040618
Labeler code 79804
Product ID 79804-618_48eb7028-8434-010d-e063-6294a90a59d6
Type HUMAN OTC DRUG
Nonproprietary name Analgesic
Dosage form CREAM
Route TOPICAL
Labeler Eagle Labs Inc.
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-06-03
Substance MENTHOL; CAMPHOR (SYNTHETIC)
Active strength .05; .03 g/g; g/g
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 Healthy Back Institute Rub On Relief
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MENTHOL .05 g/g CAMPHOR (SYNTHETIC) .03 g/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 5TJD82A1ET Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1312283 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 79804-618-03 Healthy Back Institute Rub On Relief 87.1 g in 1 PACKAGE CREAM 87.1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 79804-618 HEALTHY BACK INSTITUTE RUB ON RELIEF (ANALGESIC) CREAM [EAGLE LABS INC.] 1 Current NDC, 1 package rows 20240603_17dff3c1-3c0b-16f6-e063-6394a90a3c05.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 97 of 151 · 3,010 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 79804-618-03 79804061803 87.1 g in 1 PACKAGE (79804-618-03) 87.1 g 2024-06-03 No No Current