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 16 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mineral Ice Extreme Dry StickMENTHOLCarlin Consumer Health LLC4f81be91-92e5-1205-e063-6394a90a6e822026-06-02WarningsExact identifier
application number: M017
Kalaya Extra Strength Pain Relief Gel with ArnicaMETHYL SALICYLATE, MENTHOL, CAMPHORAvaria Health & Beauty Corpb6a6237d-b471-4102-b5df-fc389f5f92582026-06-02WarningsExact identifier
application number: M017
Biofreeze UltraflexLIDOCAINEReckitt Benckiser LLC2655974b-a67d-9f07-e063-6294a90a54e82026-06-02WarningsExact identifier
application number: M017
Biofreeze Ultraflex PlusLIDOCAINE, MENTHOLReckitt Benckiser LLC401e1843-e9a6-fda9-e063-6294a90a30732026-06-02WarningsExact identifier
application number: M017
Pain ReliefMENTHOL SPRAYOwell Naturals Brand, LLC534c871c-da35-6135-e063-6294a90aa9f62026-06-02WarningsExact identifier
application number: M017
Charm Tex FLUORIDE GelSODIUM FLUORIDEJiangsu Gold Worldworks Household Chemicals Co., Ltd.09d47bd7-1438-4ef2-85e0-9cd5eb2f763a2026-05-31WarningsExact identifier
application number: M017
Charm Tex FLUORIDESODIUM MONOFLUOROPHOSPHATEJiangsu Gold Worldworks Household Chemicals Co., Ltd.2bddc69a-0c0f-47fc-bc98-90c2ec70dd6f2026-05-31WarningsExact identifier
application number: M017
Sting Relief Prep PadBENZOCAINENINGBO TIANBO FIRST AID PRODUCT CO., LTD.9487d15d-9116-4ff8-a004-ba0835ea091e2026-05-31WarningsExact identifier
application number: M017
Careland Kinesiology Pain Relieving TapeCAMPHOR (SYNTHETIC), MENTHOL, METHYL SALICYLATEPlanet (Anhui) Pharmaceutical Co., Ltd.35d24cfc-9d34-4fd7-9312-1673b092a3b92026-05-31WarningsExact identifier
application number: M017
Walgreens Scalp Itch ReliefHYDROCORTISONEWalgreens34952272-1f9e-c642-e063-6394a90ae2bd2026-05-29WarningsExact identifier
application number: M017
Aspercreme with Lidocaine No-Mess ApplicatorLIDOCAINE HYDROCHLORIDEChattem, Inc.8092cde7-28d0-4755-b5c0-5765934e572f2026-05-29WarningsExact identifier
application number: M017
Belladona and ArnicaMENTHOLDannso Corp./d.b.a. Essential Productsfc4e63e4-cebc-49ff-8900-7238261d0fe02026-05-28WarningsExact identifier
application number: M017
Insect Sting ReliefBENZOCAINE, ALCOHOLHubei Fanjian Medical Product Co.,Ltdf30401c1-961e-44dd-e053-2a95a90a69d62026-05-28WarningsExact identifier
application number: M017
Menthol plus Camphor Pain ReliefMENTHOL, CAMPHORVeridian Healthcare4a054949-0889-7182-e063-6394a90aff5e2026-05-28WarningsExact identifier
application number: M017
Antibacterial Lidocaine Wound GelBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDECVS Pharmacy960bfe55-87f6-3e51-e053-2995a90a867d2026-05-27WarningsExact identifier
application number: M017
MyDerm Medical 5 Lidocaine Numbing Roll-OnLIDOCAINEInspec Solutions1d466be1-a780-462f-8dd4-87478da096aa2026-05-27WarningsExact identifier
application number: M017
myDerm Cooling Menthol Pain Relief with 50 Percent More MentholMENTHOLInspec Solutions LLC.d427d623-c2fd-7d6b-e053-2995a90abdc32026-05-27WarningsExact identifier
application number: M017
Caldyphen ClearPRAMOXINE HYDROCHLORIDE AND ZINC ACETATEAmerisource Bergend8802e56-649e-4494-86ee-7ca8841cc28b2026-05-27WarningsExact identifier
application number: M017
Equate Itch Relief GelITCH RELIEF GELWalmart, Inc7d7bb750-017e-c60e-e053-2991aa0ad6712026-05-26WarningsExact identifier
application number: M017
MyDerm Bite and StingBENZOCAINEMedline Industriesbf45c4dd-5814-4602-b96b-f82a449487632026-05-26WarningsExact 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