FDA.reportPublic FDA data

TriDerma LipSore Relief Cream

Product NDC
10738-920
Requested package NDC
10738-920-50
11-digit product format
107380920
Labeler code
10738
Product ID
10738-920_57a00c43-2fbd-5dd8-e063-6394a90a662f
Type
HUMAN OTC DRUG
Nonproprietary name
Allantoin Cream
Dosage form
CREAM
Route
TOPICAL
Labeler
Genuine Virgin Aloe Corporation
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-07-20
Substance
ALLANTOIN
Active strength
1.5 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
TriDerma LipSore Relief Cream
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALLANTOIN1.5 g/100g

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
57a00c34-36b1-5ecd-e063-6394a90aaa21Available on FDA.report

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TriDerma LipSore Relief CreamALLANTOIN CREAMGenuine Virgin Aloe Corporation57a00c34-36b1-5ecd-e063-6394a90aaa212026-07-20WarningsExact identifier
ndc (package): 10738-920-50
ndc (product): 10738-920
ndc11 (package): 10738092050

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
10738-920-50107380920501 TUBE in 1 PACKAGE (10738-920-50) / 14 g in 1 TUBE (10738-920-55) 1 tube2026-07-20NoNoCurrent