Home NDC 71067-359 DR. MIKES Ponos Pain Relief Cream Roll-On
Product NDC 71067-359
11-digit product format 710670359
Labeler code 71067
Product ID 71067-359_097485a4-b59a-a87a-e063-6394a90a8e52
Type HUMAN OTC DRUG
Nonproprietary name HISTAMINE DIHYDROCHLORIDE, MENTHOL
Dosage form CREAM
Route TOPICAL
Labeler Dr. Mike's Vitamins, LLC
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-08-29
Substance HISTAMINE DIHYDROCHLORIDE; MENTHOL
Active strength .3; 30 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 DR. MIKES Ponos Pain Relief Cream Roll-On
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HISTAMINE DIHYDROCHLORIDE .3 mg/g MENTHOL 30 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 3POA0Q644U Internal UNII lookup L7T10EIP3A Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2611792 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 71067-359-00 DR. MIKES Ponos Pain Relief Cream Roll-On 85 g in 1 BOTTLE, WITH APPLICATOR CREAM 85 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71067-359 DR. MIKES PONOS PAIN RELIEF CREAM ROLL-ON (HISTAMINE DIHYDROCHLORIDE, MENTHOL) CREAM [DR. MIKE'S VITAMINS, LLC] 2 Current NDC, Legacy NDC, 1 package rows 20231106_fcc45464-f1fe-4244-95a7-9b4288b0ce45.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 Marketing end Sample Exclude flag Status 71067-359-00 71067035900 85 g in 1 BOTTLE, WITH APPLICATOR (71067-359-00) 85 g 2022-08-29 0000-00-00 No No Current