AMINO ACTIVE Topical Analgesic Cream

Product NDC
82908-357
11-digit product format
829080357
Labeler code
82908
Product ID
82908-357_09e37389-88cf-6f4c-e063-6394a90a9861
Type
HUMAN OTC DRUG
Nonproprietary name
HISTAMINE DIHYDROCHLORIDE
Dosage form
CREAM
Route
TOPICAL
Labeler
VIREO SYSTEMS, INC.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-08-08
Substance
HISTAMINE DIHYDROCHLORIDE
Active strength
.25 mg/mL
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
AMINO ACTIVE Topical Analgesic Cream
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HISTAMINE DIHYDROCHLORIDE.25 mg/mL

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
1091387Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
591b1e7e-a8c0-4640-a592-4e0f3538a40eAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82908-357-00AMINO ACTIVE Topical Analgesic Cream81.33 mL in 1 JARCREAM81.332

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82908-357AMINO ACTIVE TOPICAL ANALGESIC CREAM (HISTAMINE DIHYDROCHLORIDE) CREAM [VIREO SYSTEMS, INC.]2Current NDC, Legacy NDC, 1 package rows20231112_591b1e7e-a8c0-4640-a592-4e0f3538a40e.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 30 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RICHTOFIT RAPID ACTIVE ARTHRITISMENTHOL AND CAMPHORRICHTOFIT LIMITED LIABILITY COMPANY4b1cdab1-3e50-4ec3-e063-6394a90af75e2026-03-12WarningsExact identifier
application number: M017
5Kind DMSO 4 Lidocaine HCl Pain RelievingLIDOCAINE HYDROCHLORIDE, MENTHOL5KIND TRADING LTD67d8d045-7fa0-46c2-8072-645d8823903b2026-03-11WarningsExact identifier
application number: M017
Rapid ReliefPAIN RELIEF PATCH LIDOCAINE 4%RAPID AID VIET NAM COMPANY LIMITED4ca541b4-7afe-77c5-e063-6294a90ad6922026-03-10WarningsExact identifier
application number: M017
Lidocaine Cream, 4%LIDOCAINEIPG PHARMACEUTICALS, INC.7775bfdd-7eac-4f09-b83f-fc4a16a245582026-03-10WarningsExact identifier
application number: M017
MENTHOL, CAMPHORMENTHOL, CAMPHORCHEMCO CORPORATION4c989283-9a27-e8d2-e063-6294a90a8bfa2026-03-09WarningsExact identifier
application number: M017
Prequel Anti-Itch Solution Medicated CalmingMEDICATED CALMING LOTIONThe Center Brands, LLC419fa45b-992b-676e-e063-6394a90add812026-03-09WarningsExact identifier
application number: M017
Careland Lidocaine 4 Plus Menthol Pain Relieving Gel Patches for back, neck shoulders knees and elbows with borderLIDOCAINE, MENTHOLPlanet (Anhui) Pharmaceutical Co., Ltd.1fda69f7-2bb6-42fc-bcef-677e7b3d7f012026-03-09WarningsExact identifier
application number: M017
Careland Lidocaine 4 plus menthol pain relieving gel-patches with border for kneeMENTHOL, LAUROCAPRAMPlanet (Anhui) Pharmaceutical Co., Ltd.7577625c-87eb-4639-aeab-8a2ab97033fd2026-03-09WarningsExact identifier
application number: M017
Careland Lidocaine Pain RelievingLIDOCAINEPlanet (Anhui) Pharmaceutical Co., Ltd.7de99b81-b3b3-49f1-8aa7-2ff42e1b46a42026-03-09WarningsExact identifier
application number: M017
Rapid ReliefPAIN RELIEF PATCH LIDOCAINE 4%RAPID AID VIET NAM COMPANY LIMITED4ca35030-958c-8f62-e063-6294a90a4d632026-03-09WarningsExact identifier
application number: M017
Welmate Lidocaine Pain Relieving PatchLIDOCAINEYYBA Corpcff71b75-fc4e-29ac-e053-2995a90abd502026-03-06WarningsExact identifier
application number: M017
Heal and Rescue Bunion Pain ReliefLIDOCAINE HCL, MENTHOLRooftop Consumer Health, Inc4c60d4d3-e0a9-6f93-e063-6394a90a16af2026-03-06WarningsExact identifier
application number: M017
JUST CBD - PAIN RELIEFMENTHOL, CAMPHORJust Brands LLC4c493c0b-c58e-cb56-e063-6394a90a93952026-03-05WarningsExact identifier
application number: M017
Hug a BooBoo Medicated booboo WipesBENZOCAINELights Medical Manufacture Co., Ltd.509aaafc-2ef7-4205-818c-7ff5b146e1592026-03-04WarningsExact identifier
application number: M017
CVS Foot PainLIDOCAINE HYDROCHLORIDECVS Pharmacy4c3350c3-2e3e-093c-e063-6394a90a34752026-03-04WarningsExact identifier
application number: M017
Game On SportMENTHOLNatural Essentials, Inc4c3411dc-5378-bd93-e063-6394a90a84062026-03-04WarningsExact identifier
application number: M017
Hydrocortisone 1%HYDROCORTISONETrifecta Pharmaceuticals Usa Llcf4d4a56b-b4b7-9a07-e053-2a95a90ad8532026-03-04WarningsExact identifier
application number: M017
Hydrocortisone 1%HYDROCORTISONETrifecta Pharmaceuticals Usa Llc9987165c-1a0f-dd57-e053-2a95a90ae7352026-03-04WarningsExact identifier
application number: M017
Walgreens Unscented Pain RelievingLIDOCAINE HYDROCHLORIDE, BENZYL ALCOHOLWalgreen Co.41eadb4f-2ca5-42a1-e063-6294a90ab4e22026-03-04WarningsExact identifier
application number: M017
Careland Pain Relief Patch PlusLIDOCAINEPlanet (Anhui) Pharmaceutical Co., Ltd.d55d8a9e-ed2b-4c9b-9ecb-6ec1fd43c9e32026-03-04WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1091387histamine dihydrochloride 0.025 % Topical CreamPSN591b1e7e-a8c0-4640-a592-4e0f3538a40e2
1091387histamine dihydrochloride 0.25 MG/ML Topical CreamSCD591b1e7e-a8c0-4640-a592-4e0f3538a40e2
1091387histamine dihydrochloride 0.025 % Topical CreamSY591b1e7e-a8c0-4640-a592-4e0f3538a40e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
82908-357-008290803570081.33 mL in 1 JAR (82908-357-00) 81.33 ml2022-08-080000-00-00NoNoCurrent