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 100 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Family Wellness Max Strength 1 Hydrocortisone CreamHYDROCORTISONEFamily Dollar Stores, Incbca5ac2c-45cd-44e3-98f1-317a04e44d7d2025-02-25WarningsExact identifier
application number: M017
Tylenol Precise Nighttime Pain RelievingCAMPHOR, MENTHOLKenvue Brands LLC2ef4fe16-0820-6aad-e063-6294a90a84492025-02-25WarningsExact identifier
application number: M017
LidoPro Pain ReliefCAPSAICIN AND LIDOCAINEPreferred Pharmaceuticals Inc.c259ef92-5d07-4590-adf1-3a106333eee02025-02-21WarningsExact identifier
application number: M017
Cortizone 10 Ultra Soothing Itch ReliefHYDROCORTISONEChattem, Inc.8a9e2d32-a65f-4253-8041-4146f4e3b7382025-02-21WarningsExact identifier
application number: M017
AVCOO Pain Relief Roll OnMENTHOLADP Health Limited420d8cdc-f47f-4d33-bf25-9033ff266c492025-02-19WarningsExact identifier
application number: M017
AVCOO Pain ReliefMENTHOLADP Health Limited700ce2cf-749e-40be-91c3-850d9b2168ca2025-02-19WarningsExact identifier
application number: M017
Sunburn Relief GelLIDOCAINE HCLJell Pharmaceuticals Pvt. Ltd2e7c49de-5438-4858-e063-6294a90ad98c2025-02-19WarningsExact identifier
application number: M017
VTROUY Tattoo Numbing CreamTATTOO NUMBING CREAMGuangzhou Zanming Trading Co., Ltd.2e899851-b3cd-0758-e063-6294a90afea82025-02-19WarningsExact identifier
application number: M017
Pomada Dragon Pain ReliefMENTHOL, UNSPECIFIED FORM, CAMPHOR (SYNTHETIC), AND METHYL SALICYLATEGenomma Lab USA9d98f48b-6d88-4df9-9459-7cf7ba5de0442025-02-19WarningsExact identifier
application number: M017
Pain Relieving CreamHISTAMINE DIHYDROCHLORIDEMediapower, Inc. DBA Dr Newton's And Naturals9eeea033-ae87-4d83-85d0-b8fa653a08062025-02-19WarningsExact identifier
application number: M017
Sure Complete Confidence Antiperspirant Deodorant Aerosol, RegularALUMINUM CHLOROHYDRATESodalis USA, LLC7839cf53-dbd2-4dbb-a309-1581d51f8adc2025-02-18WarningsExact identifier
application number: M017
CANNA NUMB Roll OnLIDOCAINE HYDROCHLORIDE, MENTHOLCannanumb LLCc1eb0348-3b0e-4f1c-a46b-1ff4aa165fb42025-02-17WarningsExact identifier
application number: M017
Vaporizing Chest Rub 4 oz.CAMPHOR, EUCALYPTUS OIL, MENTHOLRejoice International Inc.7173b141-123e-6cd4-e053-2a95a90a86002025-02-12WarningsExact identifier
application number: M017
Vaporizing Chest Rub 4 oz. 3 pkCAMPHOR, EUCALYPTUS OIL, MENTHOLRejoice International Inc.71c186a1-8283-2482-e053-2995a90acc1f2025-02-12WarningsExact identifier
application number: M017
Roman SwipesBENZOCAINERoman Health Ventures Inc.7f0eac8c-7235-99d8-e053-2a91aa0a634e2025-02-12WarningsExact identifier
application number: M017
SANAR NATURAL-ARNICA ROLL ON ARNICA PAIN RELIEVING WITH CAMPHOREVI LABSEVI LABS2df7658d-83d3-41ac-e063-6294a90ab1dd2025-02-12WarningsExact identifier
application number: M017
Signature Care Medicated Pain Relief PatchLIDOCAINESafeway, Inc.2165a342-5f8b-78e0-e063-6394a90a06c42025-02-12WarningsExact identifier
application number: M017
CheeZheng Pain Relieveing PlasterCAMPHORTibet Cheezheng Tibetan Medicine Co. Ltd.abcebdf1-9037-4094-93e1-ce8f20b18ea72025-02-11WarningsExact identifier
application number: M017
Tibetree Pain Relieveing Medicated PlasterCAMPHORTibet Cheezheng Tibetan Medicine Co. Ltd4216bd48-5c62-4e87-adcc-67bf7152d64d2025-02-11WarningsExact identifier
application number: M017
AsperFlexLIDOCAINEAkron Pharma Inc.ab50525e-b534-452b-8c25-2992c0cbf8622025-02-10WarningsExact 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