FDA.reportPublic FDA data

Earthmed Sport massage oil

Product NDC
82876-985
11-digit product format
828760985
Labeler code
82876
Product ID
82876-985_3b92e887-6a5f-4bbe-e063-6294a90abf90
Type
HUMAN OTC DRUG
Nonproprietary name
Allantoin
Dosage form
OIL
Route
TOPICAL
Labeler
Earthmed LLC
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-08-04
Substance
ALLANTOIN
Active strength
1 g/108.48g
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
Earthmed Sport massage oil
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALLANTOIN1 g/108.48g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
344S277G0ZInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3b92e87d-ba8d-4bac-e063-6294a90a106eAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4d7a96d5-8256-4268-9a6c-25ea66d321feProduct name120180814

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82876-985-34Earthmed Sport massage oil108.48 g in 1 BOTTLEOIL108.481

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 27 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Eucerin Eczema Relief BodyOATMEALBeiersdorf Inc9895f3c3-b00b-462c-ace0-696d688e2e042025-12-31WarningsExact identifier
application number: M016
Eucerin Eczema Relief Flare Up TreatmentOATMEALBeiersdorf Inca9ea4832-3211-40b2-accf-90ace7b9e2792025-12-31WarningsExact identifier
application number: M016
Eczema Relief Cream Body WashOATMEALBeiersdorf Incf12644e5-0ff0-de0e-e053-2995a90a09952025-12-31WarningsExact identifier
application number: M016
XIMONTH Honey Eye DropsGLYCERINShantou Ximonth Biotechnology Co., Ltd.4727f304-0bc7-2fee-e063-6394a90a01782025-12-30WarningsExact identifier
application number: M016
Kinfield Relief Balm Anti-Itch RemedyKINFIELD RELIEF BALM ANTI-ITCH REMEDYKinfield, Inc.bf394192-c789-faff-e053-2995a90a52bc2025-12-30WarningsExact identifier
application number: M016
911ALLANTOINSkinfix, Inc.f28c251e-a91b-4ed4-8224-b47c345f982f2025-12-29WarningsExact identifier
application number: M016
EXTRA STRENGTH BODYCOLLOIDAL OATMEALSkinfix, Inc.32ba5f29-c037-44dd-b5b1-59001ac507532025-12-29WarningsExact identifier
application number: M016
VITACILINA Bebe Diaper RashALLANTOIN, ZINC OXIDECompania Internacional de Comercio, S.A.P.I de C.V.39726b59-bd85-4541-80e5-4f2919842dca2025-12-29WarningsExact identifier
application number: M016
Creamy Diaper RashZINC OXIDEDavion, Inc0fdfe7d3-e4cd-6bea-e063-6394a90a37f62025-12-29WarningsExact identifier
application number: M016
Medicated Cornstarch Baby PowderACTIVE CORN STARCHDavion, Inc.e39032d1-c8cd-4a41-af10-126970b8ad382025-12-29WarningsExact identifier
application number: M016
WinCo FoodsPetroleum JellyWHITE PETROLATUMWinCo Foods, LLCf5dcf0b2-4f9f-023a-e053-2995a90a183a2025-12-28WarningsExact identifier
application number: M016
WinCo FoodsPetroleum JellyWHITE PETROLATUMWinCo Foods, LLCf5dca60a-e9bc-4161-e053-2995a90a2bcb2025-12-28WarningsExact identifier
application number: M016
Hydrating HealingHYDRATING HEALING OINTMENTNeilmed Pharmaceuticals Inc.,47106abb-4c39-07d9-e063-6394a90a4fae2025-12-28WarningsExact identifier
application number: M016
TCX SkincareCOLLOIDAL OATMEALTheraceutix, LLCc3be950b-28cf-47c2-9570-ebd46e43b1ba2025-12-24WarningsExact identifier
application number: M016
Nizoral Eczema Relief CreamCOLLOIDAL OATMEALKramer Laboratoriesda3a39d7-197f-4451-9d24-f92adbe0fc192025-12-23WarningsExact identifier
application number: M016
Healing Head to ToeALLANTOINThe Honest Company, Incdc02033f-8116-1710-e053-2995a90aff692025-12-23WarningsExact identifier
application number: M016
Honest Eczema CreamCOLLOIDAL OATMEALThe Honest Company, Inc.6f111094-425b-4a8c-b71a-5ff65f4a80002025-12-23WarningsExact identifier
application number: M016
BABY ANTI MONKEY BUTT DIAPER RASHZINC OXIDE, CALAMINEClarion Brands, LLCe4424d74-f89c-5943-42e8-bf3a38e686192025-12-23WarningsExact identifier
application number: M016
Dissolvable Microneedle Eye PatchesALLANTOINAdvaccine Biopharmaceuticals Suzhou Co., Ltd4684fa4e-5c5e-045d-e063-6394a90af0692025-12-22WarningsExact identifier
application number: M016
Good Neighbor Petroleum JellyWHITE PETROLATUMAmerisourceBergene5fb80a0-cc8c-e9e7-e053-2a95a90a455d2025-12-22WarningsExact identifier
application number: M016

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82876-985-3482876098534108.48 g in 1 BOTTLE (82876-985-34) 108.48 g2025-08-04NoNoCurrent