FDA.reportPublic FDA data

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 137 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Burn First AidBURN FIRST AIDDynarex Corporation826e08be-dffa-5a27-e053-2a91aa0a87012024-01-22WarningsExact identifier
application number: M017
Target Up and Up Pain Relief Menthol Topical Analgesic Roll-OnMENTHOLTARGET CORPORATION0f95fc55-8665-9e89-e063-6394a90a78912024-01-22WarningsExact identifier
application number: M017
CVS Health Lidocaine Pain Relief Plus MentholLIDOCAINE, MENTHOL, UNSPECIFIED FORMNatural Essentials, Inc.77978069-a1b4-473e-83c9-8320e00eea892024-01-19WarningsExact identifier
application number: M017
ZIMS MAX FREEZE LEG CRAMPSCAMPHOR, MENTHOLKOBAYASHI Healthcare International, Inc.ba26635d-95d3-4d88-93cc-1fd4fd29fd792024-01-18WarningsExact identifier
application number: M017
BurnLIDOCAINEHART Healthe95ebdac-9789-41c2-97da-2307e45387942024-01-18WarningsExact identifier
application number: M017
Medi-First Hydrocortisone 1%HYDROCORTISONE ACETATEUnifirst First Aid Corporationbd216f5d-f304-7d8d-e053-2a95a90aa9ce2024-01-17WarningsExact identifier
application number: M017
Green Guard Hydrocortisone 1%HYDROCORTISONEUnifirst First Aid Corporationbd348e2a-57b1-3f17-e053-2a95a90a8bdc2024-01-17WarningsExact identifier
application number: M017
Pain ReliefLIDOCAINE, MENTHOLHUMN Pharmaceuticals Inc6c96f94a-e724-eab3-e053-2991aa0aab882024-01-17WarningsExact identifier
application number: M017
CVS Health Lidocaine Pain ReliefLIDOCAINENatural Essentials, Inc.52e82e70-53b7-4ecb-be39-fe10c94cc4442024-01-17WarningsExact identifier
application number: M017
CVS Health XL Lidocaine Pain ReliefLIDOCAINENATURAL ESSENTIALS, INC.ec16da91-8244-402b-b8d8-84896094ac2c2024-01-17WarningsExact identifier
application number: M017
Anti-itchDIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATETarget Corporationf444b0a6-2ed3-4236-8206-3421502906752024-01-17WarningsExact identifier
application number: M017
Maximum Strength Hydrocortisone Anti-itchHYDROCORTISONE 1%Target Corporation4ff39cb8-3a20-4fe7-9829-1e882a4846682024-01-17WarningsExact identifier
application number: M017
BurnLIDOCAINE HYDROCHLORIDENantong Health & Beyond Hygienic Products Inc.eca272cb-ac8f-982b-e053-2995a90aa8b22024-01-15WarningsExact identifier
application number: M017
American Safety and First AidHYDROCORTISONE ACETATEOrazen Inceb0cfde0-c463-e9b5-e053-2a95a90a19242024-01-15WarningsExact identifier
application number: M017
American Safety and First AidHYDROCORTISONE ACETATEOrazen Inceb0cce4b-c70a-1b2d-e053-2995a90aa4aa2024-01-15WarningsExact identifier
application number: M017
Oral Pain Relief GelBENZOCAINE 20%Sled Distribution, LLCe7391302-831e-14dc-e053-2a95a90ac2362024-01-15WarningsExact identifier
application number: M017
FIRST SHIELDLIDOCAINE HCIEver Ready First Aide022bf8f-3dd8-de22-e053-2995a90a219b2024-01-15WarningsExact identifier
application number: M017
FlexigenMENTHOL 1.25%Derma Care Research Labs, LLCe9ae2682-59b4-e796-e053-2995a90af9212024-01-15WarningsExact identifier
application number: M017
Vita-P Oral and NasalMENTHOL 1%Beijing HKKY Medical Tech. Co., Ltd.537c3843-1c92-41c6-b724-52701bbddeab2024-01-13WarningsExact identifier
application number: M017
Caring mill Lidocaine Aloe Gel Burn and Pain ReliefLIDOCAINE HYDROCHLORIDEFSA Store Inc.0ec20c87-1681-dd23-e063-6394a90a291c2024-01-12WarningsExact 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