Pain Relieving Cream

Product NDC
85063-101
11-digit product format
850630101
Labeler code
85063
Product ID
85063-101_de7597a0-26c9-4a4b-b2b7-10ded0901117
Type
HUMAN OTC DRUG
Nonproprietary name
Histamine Dihydrochloride
Dosage form
CREAM
Route
TOPICAL
Labeler
Mediapower, Inc. DBA Dr Newton's And Naturals
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-02-20
Substance
HISTAMINE DIHYDROCHLORIDE
Active strength
.05 g/100g
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
Pain Relieving Cream
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HISTAMINE DIHYDROCHLORIDE.05 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1542820Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
9eeea033-ae87-4d83-85d0-b8fa653a0806Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85063-101-85Pain Relieving Cream85 g in 1 BOTTLE, PUMPCREAM851

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
85063-101PAIN RELIEVING CREAM (HISTAMINE DIHYDROCHLORIDE) CREAM [MEDIAPOWER, INC. DBA DR NEWTON'S AND NATURALS]1Current NDC, 1 package rows20250306_9eeea033-ae87-4d83-85d0-b8fa653a0806.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 131 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ling Nam Hung FarMETHYL SALICYLATELing Nam Medicine Factory (H.K.) Ltd.b6916b6e-b7eb-1eb7-e053-2995a90ae6fb2024-07-18WarningsExact identifier
application number: M017
itch reliefDIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATEBionpharma Inc.178ed513-4f22-8f11-e063-6294a90a109b2024-07-16WarningsExact identifier
application number: M017
POWERECT Benzocaine Male Delay GelBENZOCAINESKINS SEXUAL HEALTH LIMITED2fafe1f2-a31e-4b2a-bc51-81e16b319c3a2024-07-16WarningsExact identifier
application number: M017
SKINS DELAY Climax Control Benzocaine GelBENZOCAINESKINS SEXUAL HEALTH LIMITED53730576-2609-4f28-8bfa-a1ceea698b832024-07-16WarningsExact identifier
application number: M017
TIDL PAIN RELIEF CRYO THERAPY Unscented formula Spray.PAIN RELIEF CRYO THERAPY UNSCENTED FORMULA SPRAYShenzhen Sam Technology Co., Ltd.1d1a0346-3b00-4803-e063-6294a90aec6d2024-07-13WarningsExact identifier
application number: M017
Tidl Pain Relief Evening Therapy Spray.PAIN RELIEF EVENING THERAPY SPRAYShenzhen Sam Technology Co., Ltd.1d1a2f4a-7b25-e595-e063-6394a90a00d52024-07-13WarningsExact identifier
application number: M017
TIDL PAIN RELIEF HEAT THERAPY ROLL-ONPAIN RELIEF HEAT THERAPY ROLL-ONShenzhen Sam Technology Co., Ltd.1d0b7b8f-9e5d-00f7-e063-6394a90af87c2024-07-12WarningsExact identifier
application number: M017
TIDL PAIN RELIEF CRYO THERAPY original formula Spray.PAIN RELIEF CRYO THERAPY ORIGINAL FORMULA SPRAYShenzhen Sam Technology Co., Ltd.1d0b94ec-f956-dff2-e063-6294a90aca4a2024-07-12WarningsExact identifier
application number: M017
TIDL PAIN RELIEF CRYO THERAPY MAX Strength Spray.PAIN RELIEF CRYO THERAPY MAX STRENGTH SPRAYShenzhen Sam Technology Co., Ltd.1d0bf4f9-6b02-6cec-e063-6294a90a36c72024-07-12WarningsExact identifier
application number: M017
Burn ReliefLIDOCAINE HCI 2.0%Trifecta Pharmaceuticals USA, LLC.e5e524cd-bb22-715f-e053-2995a90ab5d32024-07-12WarningsExact identifier
application number: M017
Ralli Rapid Pain ReliefMENTHOLTroy Manufacturing, Inc.1d10e3ca-dc93-8e1a-e063-6394a90a47c02024-07-12WarningsExact identifier
application number: M017
TIDL PAIN RELIEF HEAT THERAPY Spray.PAIN RELIEF HEAT THERAPY SPRAYShenzhen Sam Technology Co., Ltd.1d199826-1b27-b6e7-e063-6394a90a69ad2024-07-12WarningsExact identifier
application number: M017
Tidl Pain Relief Morning Therapy Spray.PAIN RELIEF MORNING THERAPY SPRAYShenzhen Sam Technology Co., Ltd.1d19d070-3818-73de-e063-6394a90a89582024-07-12WarningsExact identifier
application number: M017
Hydrocortisone with aloeHYDROCORTISONE WITH ALOE ANTI ITCHNeilMed Pharmaceuticals Inc.032b9f58-5f64-04dd-e063-6294a90a6bb92024-07-10WarningsExact identifier
application number: M017
Octagon Pain ReliefMENTHOL, UNSPECIFIED FORMNATURAL ESSENTIALS, INC.9926f733-1506-4224-9d70-b1813cd81ec32024-07-08WarningsExact identifier
application number: M017
LidoReal PatchLIDOCAINE AND MENTHOLFORREAL PHARMACEUTICALS LLC19f1c037-b4b8-47b0-b0f9-036691c1d3072024-07-05WarningsExact identifier
application number: M017
Lip Medex Lip BalmPETROLATUM, CAMPHOR (SYNTHETIC), MENTHOL, UNSPECIFIED FORM, AND PHENOLBlistex Inc.988f97e8-a59f-4bc0-9d71-60607364a6862024-07-01WarningsExact identifier
application number: M017
Maybelline New York BABY LIPS DR RESCURE MENTHOL EXTERNAL ANALGESIC MEDICATED BALMMENTHOLL'Oreal USA Products Incd580982f-dda6-4b03-bf84-342b9f2c6d932024-06-29WarningsExact identifier
application number: M017
Lip Medex CherryPETROLATUM, CAMPHOR (SYNTHETIC), AND MENTHOL, UNSPECIFIED FORMBlistex Inc.fa8b3fb1-08e5-4876-9c4a-6aa8c9f23af82024-06-28WarningsExact identifier
application number: M017
10% Methyl Salicylate Pain Relief Patch10% METHYL SALICYLATEAkron Coating & Adhesives1be1f1ce-3238-a8ed-e063-6294a90a5aed2024-06-27Exact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1542820histamine dihydrochloride 0.05 % Topical CreamPSN9eeea033-ae87-4d83-85d0-b8fa653a08061
1542820histamine dihydrochloride 0.5 MG/ML Topical CreamSCD9eeea033-ae87-4d83-85d0-b8fa653a08061
1542820histamine dihydrochloride 0.05 % Topical CreamSY9eeea033-ae87-4d83-85d0-b8fa653a08061

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85063-101-858506301018585 g in 1 BOTTLE, PUMP (85063-101-85) 85 g2025-02-20NoNoCurrent