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
IngredientStrength
HISTAMINE DIHYDROCHLORIDE.3 mg/g
MENTHOL30 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3POA0Q644UInternal UNII lookup
L7T10EIP3AInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2611792Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
fcc45464-f1fe-4244-95a7-9b4288b0ce45Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71067-359-00DR. MIKES Ponos Pain Relief Cream Roll-On85 g in 1 BOTTLE, WITH APPLICATORCREAM852

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71067-359DR. MIKES PONOS PAIN RELIEF CREAM ROLL-ON (HISTAMINE DIHYDROCHLORIDE, MENTHOL) CREAM [DR. MIKE'S VITAMINS, LLC]2Current NDC, Legacy NDC, 1 package rows20231106_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 91 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LidocaineLIDOCAINEStratus Pharmaceuticals Inc5eb6574c-2066-4390-befc-8e5d2dd6ede22025-06-12WarningsExact identifier
application number: M017
CHINESE RED TIGER LIDOCAINE PATCHES4% LIDOCAINE, 1%MENTHOLGuangzhou Zhupuyou E-commerce Co., Ltd36b9a7a2-5832-4ce5-e063-6294a90aed122025-06-12WarningsExact identifier
application number: M017
PRO COLD HOT Pain Relief Gel Roll-On (Plantar Fasciitis)MENTHOLGuangzhou Zhupuyou E-commerce Co., Ltd375bc794-3289-e610-e063-6294a90a4f9b2025-06-12WarningsExact identifier
application number: M017
Methyl Salicylate 10% Pain RelievingMETHYL SALICYLATEPureTek Corporation376493eb-5142-db6d-e063-6294a90a1e732025-06-12WarningsExact identifier
application number: M017
Free and Pure Cold Therapy Pain ReliefMENTHOLWalgreen Co.22cbbffc-f876-411e-e063-6394a90a1b382025-06-12WarningsExact identifier
application number: M017
Methylten 25% Pain RelievingMETHYL SALICYLATEPureTek Corporation3767b97e-ab0c-ac26-e063-6394a90a00cf2025-06-12WarningsExact identifier
application number: M017
SPF 50 Mineral SunscreenZINC OXIDEInspec Solutions, LLC36af9a0a-536b-ee1a-e063-6394a90aace42025-06-11WarningsExact identifier
application number: M017
PLANTAR FASCIITIS Relief Gel Roll-OnMENTHOLGuangzhou Zhupuyou E-commerce Co., Ltd37570149-dae1-a4f2-e063-6294a90a32452025-06-11WarningsExact identifier
application number: M017
Diabecin CS CreamMENTHOL, CAPSAICINPuretek Corporation33ef2233-7a66-ee65-e063-6294a90ac55a2025-06-10WarningsExact identifier
application number: M017
KINKAN COOLDIPHENHYDRAMINE HYDROCHLORIDE, MENTHOLKINKANDO CO., LTD .82011efe-825c-4102-b6f1-59eff4c8040a2025-06-10WarningsExact identifier
application number: M017
MQUPIN Knee PatchKNEE PATCHZhengzhou Miaoqi Medical Technology Co., Ltd.37438a70-dab7-ecb5-e063-6394a90afefb2025-06-10WarningsExact identifier
application number: M017
ORTHOGEL Menthol 3.5% Roll OnMENTHOLLiquidCapsule Manufacturing LLC99424327-67e9-43b5-a117-94c9643413c12025-06-07WarningsExact identifier
application number: M017
Lightning Pain ReliefMENTHOLEbanel Laboratories, Inc36edbc3f-501c-c1ea-e063-6394a90af6af2025-06-06WarningsExact identifier
application number: M017
FREEZE IT Menthol Roll OnMENTHOLLiquidCapsule Manufacturing LLC33094afe-db9d-4b92-8047-6dd611484fc92025-06-05WarningsExact identifier
application number: M017
Band Aid Antiseptic CleansingBENZALKONIUM CHLORIDE, PRAMOXINE HCLKenvue Brands LLCd55e6b09-0587-61a9-e053-2995a90afaf52025-06-05WarningsExact identifier
application number: M017
FREEZE IT MentholMENTHOLLiquidCapsule Manufacturing LLCde8d8007-5718-4fb4-a8c6-4650d2ca9c8f2025-06-05WarningsExact identifier
application number: M017
HEEL PAIN Relief Gel Roll-OnMENTHOLGuangzhou Zhupuyou E-commerce Co., Ltd36bacb5f-c1af-2e97-e063-6394a90afe5c2025-06-04WarningsExact identifier
application number: M017
Capsaicin 0.075% CreamCAPSAICINViolaCare, Inc.30911225-a6d7-4b2b-9005-b733373e28772025-06-04WarningsExact identifier
application number: M017
LidoGuardLIDOCAINE HCLViolaCare, Inc.531383aa-4f0f-4fe0-91f4-d809b39f160f2025-06-04WarningsExact identifier
application number: M017
HealthWise Lidocaine and MentholLIDOCAINE AND MENTHOLVeridian Healthcare36c27642-f913-1aad-e063-6294a90a43432025-06-04WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2611792histamine dihydrochloride 0.03 % / menthol 3 % Topical CreamPSNfcc45464-f1fe-4244-95a7-9b4288b0ce452
2611792histamine dihydrochloride 0.3 MG/ML / menthol 30 MG/ML Topical CreamSCDfcc45464-f1fe-4244-95a7-9b4288b0ce452
2611792histamine dihydrochloride 0.03 % / menthol 3 % Topical CreamSYfcc45464-f1fe-4244-95a7-9b4288b0ce452

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71067-359-007106703590085 g in 1 BOTTLE, WITH APPLICATOR (71067-359-00) 85 g2022-08-290000-00-00NoNoCurrent