FDA.reportPublic FDA data

NDC 83107-019-01 - Analpram HC

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
83107-019
Requested NDC
83107-019-01
Package NDCs from labels
83107-019-12, 83107-019-30, 83107-019-01
Manufacturer
Legacy Pharma USA Inc.
Effective date
2026-03-24
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Analpram HC ® hydrocortisone acetate 2.5% pramoxine HCl 1% Cream 2.5%Legacy Pharma USA Inc.2026-03-24HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83107-019-01Analpram HC28 g in 1 TUBE, WITH APPLICATORCREAM282
83107-019-12Analpram HC12 in 1 CARTONCREAM122
83107-019-12Analpram HC4 g in 1 TUBE, WITH APPLICATORCREAM42
83107-019-30Analpram HC30 in 1 CARTONCREAM302
83107-019-30Analpram HC4 g in 1 TUBE, WITH APPLICATORCREAM42

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
83107-019-01GM - Gram83107-019d56a377c-f08e-44d5-bea4-2527aa106bce12025-10-14
83107-019-12GM - Gram83107-01905f54610-7ff3-4523-809b-0b988ffd5b3e12026-02-05

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 10 of 31 · 615 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pur-WashEYEWASHNiagara Pharmaceuticals, Inc.0d43b1c1-2699-37f1-e054-00144ff88e882025-11-24WarningsExact identifier
unii: 059QF0KO0R
Eyewash Station Additive ConcentrateCHLORHEXIDINE GLUCONATE AND PROPYLENE GLYCOLNiagara Pharmaceuticals Inc.362a6b6d-862d-4322-87a8-5b3a07fbe1742025-11-24WarningsExact identifier
unii: 6DC9Q167V3
PUR-WASHWATERNiagara Pharmaceuticals Inc.777e1559-786f-8d54-e053-2991aa0aa98d2025-11-24WarningsExact identifier
unii: 059QF0KO0R
PUR-WASHWATERNiagara Pharmaceuticals Inc.7289103a-5cbf-42f4-8848-e827149a43ca2025-11-24WarningsExact identifier
unii: 059QF0KO0R
Eyewash Additive ConcentrateWATER AND PROPYLENE GLYCOLHaws Corporationdd168403-398c-41ff-b1df-d93e4ff39de32025-11-20WarningsExact identifier
unii: 6DC9Q167V3
unii: 059QF0KO0R
CVS Anti-ItchPRAMOXINE HCLCVS87fc476a-5b12-7383-e053-2995a90a530b2025-11-19WarningsExact identifier
unii: 88AYB867L5
Walgreen Anti-ItchPRAMOXINE HCLWalgreensb5f9d1c5-891e-4377-e053-2995a90aa2812025-11-19WarningsExact identifier
unii: 88AYB867L5
Hemorrhoidal CreamGLYCEROL, PHENYLEPHINE, PRAMOXINE, PETROLATUMTrifecta Pharmaceuticals Usa Llc804d7b1f-1be8-50c9-e053-2a91aa0a35d02025-11-18WarningsExact identifier
unii: 88AYB867L5
Sterile WaterWATERFresenius Kabi USA, LLCfd823bef-c14c-4708-a18a-8aaa8470412f2025-11-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Calamine Plus Pramoxine HClCALAMINE PLUS SPRAYKroger Co.6b3e7aac-395f-48cf-9c5e-f7e163724aef2025-11-17WarningsExact identifier
unii: 88AYB867L5
Calamine Plus Pramoxine HClCALAMINE PLUS SPRAYHY-VEE, INC415ecfe9-3145-f23e-e063-6394a90adfd82025-11-17WarningsExact identifier
unii: 88AYB867L5
Hydrocortisone AcetateHYDROCORTISONE ACETATEMarlex Pharmaceuticals, Inc.e60473f7-fd00-a477-e053-2a95a90ad4dd2025-11-13Adverse reactionsExact identifier
unii: 3X7931PO74
Eyesaline Eyewash ConcentratePURIFIED WATERHoneywell Safety Products USA, Inc.3765c251-eb14-d60f-e063-6294a90a6a4d2025-11-12WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Emergency EyewashPURIFIED WATERHoneywell Safety Products USA, Inc.37f244fd-c02f-e66a-e063-6394a90aed812025-11-12WarningsExact identifier
unii: 059QF0KO0R
Analpram HCHYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDESebela Pharmaceuticals Inc.fecf8380-3bb5-11e5-98c5-0002a5d5c51b2025-11-08Adverse reactionsExact identifier
rxcui: 1362211
rxcui: 1294025
unii: 88AYB867L5
unii: 3X7931PO74
Analpram HCHYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDESebela Pharmaceuticals Inc.1469733e-1723-4b8c-be33-ed8dfafd65e22025-11-08Adverse reactionsExact identifier
application number: ANDA085979
unii: 88AYB867L5
unii: 3X7931PO74
PramosoneHYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDESebela Pharmaceuticals Inc.f207bdff-2f41-4eee-818e-198b6462863e2025-11-08Adverse reactionsExact identifier
unii: 88AYB867L5
unii: 3X7931PO74
STERILE WATERWATERHenry Schein, Inc.f4087143-9868-4308-b96c-43657ee8ec282025-11-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Calamine PlusCALAMINE PLUS PRAMOXINE HCLChain Drug Marketing Association Inc1a3f8819-58cf-8923-e063-6394a90a37af2025-11-06WarningsExact identifier
unii: 88AYB867L5
Bacteriostatic WaterBACTERIOSTATIC WATERProPharma Distribution42c6938e-f747-ae13-e063-6294a90a59a32025-11-04Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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