FDA.reportPublic FDA data

Glucosamine Cream EXTRA STRENGTH

Product NDC
78983-101
11-digit product format
789830101
Labeler code
78983
Product ID
78983-101_45c7fbb8-7155-d694-e063-6394a90a236e
Type
HUMAN OTC DRUG
Nonproprietary name
HISTAMINE DIHYDROCHLORIDE
Dosage form
CREAM
Route
TOPICAL
Labeler
IDEAZ, LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-09-08
Substance
HISTAMINE DIHYDROCHLORIDE
Active strength
.05 g/100g
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
Glucosamine Cream EXTRA STRENGTH
Listing expiration
2026-12-31

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
f4d414b7-89e7-ad65-e053-2a95a90a25d4Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78983-101-85Glucosamine Cream EXTRA STRENGTH85 g in 1 TUBECREAM855

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78983-101GLUCOSAMINE CREAM EXTRA STRENGTH (HISTAMINE DIHYDROCHLORIDE) CREAM [IDEAZ, LLC]4Current NDC, 1 package rows20250101_f4d414b7-89e7-ad65-e053-2a95a90a25d4.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 55 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Magsoothium BodyMENTHOL, CAPSAICINUbu/Elements, Inc.f604d30c-b17c-ec01-e053-2a95a90aa3042025-12-15WarningsExact identifier
application number: M017
Salonpas pain relieving JETMENTHOL, METHYL SALICYLATEHisamitsu Pharmaceutical Co., Inc.dd1ea3bf-891a-402e-8f43-14302bc9c3e52025-12-15WarningsExact identifier
application number: M017
Herbal Tendon Bone ReliefCAMPHOR MINTGuchutang Biotechnology (Longyan) Co., Ltd.45cf4040-9751-d24b-e063-6294a90aff272025-12-13WarningsExact identifier
application number: M017
ElixirLidoFastLIDOCAINE 5% CREAMELIXIR HEALTHCARE USA, LLC.45de5a3d-06c2-aa02-e063-6294a90a63d32025-12-13WarningsExact identifier
application number: M017
MEDI FIRST PLUSHYDROCORTISONE ACETATEOrazen Inc5781124a-60f4-4a64-80b7-ce5f28d495b52025-12-12WarningsExact identifier
application number: M017
MEDI-FIRSTHYDROCORTISONE ACETATEOrazen Incaeffd85c-58a7-4d64-bf94-977b6fbbe7132025-12-12WarningsExact identifier
application number: M017
Joint and Muscle ReliefMENTHOLSmart Cookie Solutions Inc.45c24d56-4dc9-2884-e063-6294a90a52cc2025-12-12WarningsExact identifier
application number: M017
PopstarDELAY SPRAYPineapple Brands LLC293b2da9-1261-0358-e063-6394a90aa08c2025-12-12WarningsExact identifier
application number: M017
Careland Pain Relief PlusCAMPHOR, MENTHOL, METHYL SALICYLATEPlanet (Anhui) Pharmaceutical Co., Ltd.d9e63ddd-d003-45fa-b156-7f4452c28cbd2025-12-12WarningsExact identifier
application number: M017
Glucosamine Cream EXTRA STRENGTHHISTAMINE DIHYDROCHLORIDEIDEAZ, LLCf4d414b7-89e7-ad65-e053-2a95a90a25d42025-12-12WarningsExact identifier
application number: M017
ndc (product): 78983-101
ARTHRITISMENTHOLSmith Amish, LLC20c36972-b695-1241-e063-6394a90adf632025-12-12WarningsExact identifier
application number: M017
FOOTMENTHOLSmith Amish, LLC20c48537-f55f-c10f-e063-6394a90a4cca2025-12-12WarningsExact identifier
application number: M017
Joint EaseMENTHOLSmith Amish, LLC20c4a0f8-bdc6-d89a-e063-6294a90aa8d82025-12-12WarningsExact identifier
application number: M017
Toast Screamin HotCAPSAICINIDEAZ, LLC331207e6-b8ac-b169-e063-6394a90ac1692025-12-12WarningsExact identifier
application number: M017
Pain Relief Gel-PatchLIDOCAINEKORVIA GLOBAL Inc.45ccfcae-a307-1c5f-e063-6294a90acf892025-12-12WarningsExact identifier
application number: M017
Lidospot patchLIDOCAINE AND MENTHOLFabrication Enterprises Inc3a6e94c4-1ca6-e77a-e063-6394a90a4bfc2025-12-12WarningsExact identifier
application number: M017
LETEBEE LIGHT neuropathy pain relief cream for feetMENTHOLGuangdong Aimu Biological Technology Co., Ltd45a99afc-15ec-76c2-e063-6294a90a22202025-12-11WarningsExact identifier
application number: M017
CintheraLIDOCAINEStrand Health Group2746e5b2-be2d-f2d2-e063-6394a90a36902025-12-11WarningsExact identifier
application number: M017
Equate Cool and Heat Pain Relieving LiquidCOOL AND HEAT PAIN RELIEFWalmart, Inc.ad156685-3bd5-6837-e053-2995a90ac7882025-12-11WarningsExact identifier
application number: M017
HUMCO Camphor SpiritCAMPHOR 10%Humco Holding Group, Inc.9a0ef0a3-3c79-41b2-8193-424a3ef9886f2025-12-11WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1542820histamine dihydrochloride 0.05 % Topical CreamPSNf4d414b7-89e7-ad65-e053-2a95a90a25d45
1542820histamine dihydrochloride 0.5 MG/ML Topical CreamSCDf4d414b7-89e7-ad65-e053-2a95a90a25d45
1542820histamine dihydrochloride 0.05 % Topical CreamSYf4d414b7-89e7-ad65-e053-2a95a90a25d45

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
78983-101-857898301018585 g in 1 TUBE (78983-101-85) 85 g2022-09-08NoNoCurrent