FDA.reportPublic FDA data

Spotex

Product NDC
82160-126
11-digit product format
821600126
Labeler code
82160
Product ID
82160-126_d3942c44-25cd-788b-e053-2a95a90aab2b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Erythromycin
Dosage form
GEL
Route
TOPICAL
Labeler
Pella Pharmaceuticals Co. Ltd
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2013-09-10
Marketing end
0000-00-00
Substance
ERYTHROMYCIN
Active strength
1200 mg/30g
Pharmacologic classes
Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [CS]
NDC exclude flag
No
Listing certified through
2022-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct82160-126IInactivated by FDA2026-10-05
excluded packagepackage82160-12682160-126-01IInactivated by FDA2026-10-05

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d329c2e1-5ae8-4e64-aea0-77ecea3fa1abProduct name320250717
3b331500-3b74-bd2b-fede-d46839f2f4d5Product name620240313
fdae2630-eae0-4769-abfd-8f33d5b771b4Product name320240202
8c898317-b543-1e4e-254f-84cec2f3f57eProduct name220191002
64ae94c0-3212-d73a-92da-9e6dd85c6ebeProduct name220180118
edcfa1cf-915f-1a4c-d0aa-508cc66e70d9Product name220170816
ad75fcfd-a339-42a1-9c60-43ba2c654cfaProduct name120170810
57850177-5927-151f-e1fa-7e2ca47f81e5Product name120140508
8ee71591-1d8f-e24e-242b-bfef131e3168Product name120140508
bff5cf99-0f45-fa15-2a76-b160c3c4cc3cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82160-126-01Spotex30 g in 1 TUBEGEL30130
82160-126-01Spotex1 in 1 CARTONGEL1130

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82160-126SPOTEX (ERYTHROMYCIN) GEL [PELLA PHARMACEUTICALS CO. LTD]130Legacy NDC, 2 package rows20250101_d0485ea3-984d-3193-e053-2995a90a078f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
250697erythromycin 4 % Topical GelPSNd0485ea3-984d-3193-e053-2995a90a078f130
250697erythromycin 0.04 MG/MG Topical GelSCDd0485ea3-984d-3193-e053-2995a90a078f130
250697erythromycin 4 % Topical GelSYd0485ea3-984d-3193-e053-2995a90a078f130

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
82160-126-01821600126011 TUBE in 1 CARTON (82160-126-01) > 30 g in 1 TUBE1 tube2013-09-100000-00-00NoNoCurrent