FDA.reportPublic FDA data

Amino Mask

Product NDC
49825-128
Requested package NDC
49825-128-04
11-digit product format
498250128
Labeler code
49825
Product ID
49825-128_71a6246e-48b9-4d48-835e-9b96f23c8c16
Type
HUMAN OTC DRUG
Nonproprietary name
Sulfur
Dosage form
CREAM
Route
TOPICAL
Labeler
Bioelements
Application
part358H
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2013-06-14
Marketing end
0000-00-00
Substance
SULFUR
Active strength
5 g/100mL
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage49825-12849825-128-04DDiscontinued by firm2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 6 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
49825-128-022025-01-09Amino Mask
49825-128-042025-01-09Amino Mask
49825-128-022024-01-30Amino Mask
49825-128-042024-01-30Amino Mask

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SULFURACTIVE INGREDIENT70FD1KFU70AMINO MASK BIOELEMENTS (SULFUR) CREAM [BIOELEMENTS]3
SULFURACTIVE MOIETY70FD1KFU70AMINO MASK BIOELEMENTS (SULFUR) CREAM [BIOELEMENTS]3
ALLANTOININACTIVE INGREDIENT344S277G0ZAMINO MASK BIOELEMENTS (SULFUR) CREAM [BIOELEMENTS]3
BENTONITEINACTIVE INGREDIENTA3N5ZCN45CAMINO MASK BIOELEMENTS (SULFUR) CREAM [BIOELEMENTS]3
BIOTININACTIVE INGREDIENT6SO6U10H04AMINO MASK BIOELEMENTS (SULFUR) CREAM [BIOELEMENTS]3
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SAMINO MASK BIOELEMENTS (SULFUR) CREAM [BIOELEMENTS]3
CHONDRUS CRISPUSINACTIVE INGREDIENTOQS23HUA1XAMINO MASK BIOELEMENTS (SULFUR) CREAM [BIOELEMENTS]3
ETHYLHEXYLGLYCERININACTIVE INGREDIENT147D247K3PAMINO MASK BIOELEMENTS (SULFUR) CREAM [BIOELEMENTS]3
GLYCERININACTIVE INGREDIENTPDC6A3C0OXAMINO MASK BIOELEMENTS (SULFUR) CREAM [BIOELEMENTS]3
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4AMINO MASK BIOELEMENTS (SULFUR) CREAM [BIOELEMENTS]3
GLYCYRRHIZINATE DIPOTASSIUMINACTIVE INGREDIENTCA2Y0FE3FXAMINO MASK BIOELEMENTS (SULFUR) CREAM [BIOELEMENTS]3
GREEN TEA LEAFINACTIVE INGREDIENTW2ZU1RY8B0AMINO MASK BIOELEMENTS (SULFUR) CREAM [BIOELEMENTS]3
HONEYINACTIVE INGREDIENTY9H1V576FHAMINO MASK BIOELEMENTS (SULFUR) CREAM [BIOELEMENTS]3
KAOLININACTIVE INGREDIENT24H4NWX5COAMINO MASK BIOELEMENTS (SULFUR) CREAM [BIOELEMENTS]3
KIWI FRUITINACTIVE INGREDIENT71ES77LGJCAMINO MASK BIOELEMENTS (SULFUR) CREAM [BIOELEMENTS]3
LACTIC ACIDINACTIVE INGREDIENT33X04XA5ATAMINO MASK BIOELEMENTS (SULFUR) CREAM [BIOELEMENTS]3
LAVENDER OILINACTIVE INGREDIENTZBP1YXW0H8AMINO MASK BIOELEMENTS (SULFUR) CREAM [BIOELEMENTS]3
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7UAMINO MASK BIOELEMENTS (SULFUR) CREAM [BIOELEMENTS]3
NIACINAMIDEINACTIVE INGREDIENT25X51I8RD4AMINO MASK BIOELEMENTS (SULFUR) CREAM [BIOELEMENTS]3
PANTHENOLINACTIVE INGREDIENTWV9CM0O67ZAMINO MASK BIOELEMENTS (SULFUR) CREAM [BIOELEMENTS]3
PEG-100 STEARATEINACTIVE INGREDIENTYD01N1999RAMINO MASK BIOELEMENTS (SULFUR) CREAM [BIOELEMENTS]3
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TAMINO MASK BIOELEMENTS (SULFUR) CREAM [BIOELEMENTS]3
POLYOXYL 20 CETOSTEARYL ETHERINACTIVE INGREDIENTYRC528SWUYAMINO MASK BIOELEMENTS (SULFUR) CREAM [BIOELEMENTS]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAMINO MASK BIOELEMENTS (SULFUR) CREAM [BIOELEMENTS]3
WATERINACTIVE INGREDIENT059QF0KO0RAMINO MASK BIOELEMENTS (SULFUR) CREAM [BIOELEMENTS]3
WINE GRAPEINACTIVE INGREDIENT3GOV20705GAMINO MASK BIOELEMENTS (SULFUR) CREAM [BIOELEMENTS]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49825-128AMINO MASK BIOELEMENTS (SULFUR) CREAM [BIOELEMENTS, INC.]7Legacy NDC20250112_0280e008-8f9d-4bb8-897b-3e5fbb49aa1e.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49825-128-04498250128041 JAR in 1 BOX (49825-128-04) > 118 mL in 1 JAR (49825-128-03) 1 jar2013-06-140000-00-00NoNoCurrent