FDA.reportPublic FDA data

NDC 63629-8669-01 - hydrocortisone acetate pramoxine hcl

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
63629-8669
Requested NDC
63629-8669-01
Package NDCs from labels
63629-8669-1, 63629-8669-01
Manufacturer
Bryant Ranch Prepack
Effective date
2023-07-18
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
hydrocortisone acetate pramoxine hcl - Bryant Ranch PrepackBryant Ranch Prepack2023-07-18HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-8669-1hydrocortisone acetate pramoxine hcl28.35 g in 1 TUBECREAM28.35104
63629-8669-1hydrocortisone acetate pramoxine hcl1 in 1 CARTONCREAM1104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8669HYDROCORTISONE ACETATE PRAMOXINE HCL CREAM [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 2 package rows20230719_3c5e1833-9908-4e4f-bdf2-7a28c14a585c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-8669-1GM - Gram63629-8669db390f32-9ce1-40c5-8a73-c3b080121e6d12023-08-08

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 13 of 31 · 613 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Calamine Plus Pramoxine HClCALAMINE PLUS SPRAYFSA Store Inc.3cd18f96-34f7-3f2c-e063-6294a90a3b7e2025-08-19WarningsExact identifier
unii: 88AYB867L5
PROCTOFOAM NSPRAMOXINE HYDROCHLORIDEViatris Specialty LLCcddc8d81-21b8-11e4-8c21-0800200c9a662025-08-15WarningsExact identifier
unii: 88AYB867L5
Natureplex Antibiotic Plus Pain, Itch, Scar ReliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDENatureplex LLCf0af8829-72fb-46b1-9328-6f4920710bb12025-08-15WarningsExact identifier
unii: 88AYB867L5
Systane COMPLETEPROPYLENE GLYCOLAlcon Laboratories, Inc.2df0de02-a3e2-471a-9e10-040c3fba75fe2025-08-08WarningsExact identifier
unii: 6DC9Q167V3
Systane BalancePROPYLENE GLYCOLAlcon Laboratories, Inc.c7b1a03a-a5f2-409e-a34a-d6f166671de52025-08-07WarningsExact identifier
unii: 6DC9Q167V3
HYDROCORTISONEHYDROCORTISONEHF Acquisition Co LLC, DBA HealthFirst3ba6a5ec-fda2-b2a6-e063-6294a90ac9b62025-08-05WarningsExact identifier
unii: 3X7931PO74
Hydrocortisone AcetateHYDROCORTISONE ACETATEMajor Pharmaceuticals1281a82d-df00-4421-9c0d-951f8f9a94222025-08-05Adverse reactionsExact identifier
unii: 3X7931PO74
Systane UltraPOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.0537c23a-15f7-be64-1231-a6c93468e9a82025-07-30WarningsExact identifier
unii: 6DC9Q167V3
SystanePOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.1d679d0f-cec2-a644-79cd-079607254bb92025-07-30WarningsExact identifier
unii: 6DC9Q167V3
Systane Ultra Preservative FreePOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.751fb85f-6683-4b0a-a650-324d4a74c5de2025-07-30WarningsExact identifier
unii: 6DC9Q167V3
Systane COMPLETE PFPROPYLENE GLYCOLAlcon Laboratories, Inc.99b63d62-1cf0-4f28-8760-773917c2538a2025-07-29WarningsExact identifier
unii: 6DC9Q167V3
Rugby Caldyphen ClearPRAMOXINE HYDROCHLORIDE AND ZINC ACETATE LOTIONRugby Laboratories9af3a740-ef97-26ce-e053-2a95a90a0ee12025-07-28WarningsExact identifier
unii: 88AYB867L5
Hydrocortisone Acetate CreamHYDROCORTISONE ACETATE CREAMAllegis Holdings LLC3b008546-afa5-fe5a-e063-6394a90adb3b2025-07-28Adverse reactionsExact identifier
unii: 3X7931PO74
Triple Antibiotic plus Pain ReliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDESTRATEGIC SOURCING SERVICES LLC6a61c900-2dfc-4c07-8ae5-32ffbd89d2b62025-07-21WarningsExact identifier
unii: 88AYB867L5
Live Better Triple Antibiotic plus Pain ReliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDEThe Great Atlantic & Pacific Tea Company7e7a0b4c-67a9-42f3-aacd-2606fde250902025-07-15WarningsExact identifier
unii: 88AYB867L5
Triple Antibiotic Plus Pain ReliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDEFRED'S, INC.a44db5d1-7a74-44aa-9aa7-6247e771aaf22025-07-15WarningsExact identifier
unii: 88AYB867L5
Shopko Triple Antibiotic plus Pain ReliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDEShopko Stores Operating Co., LLC5a9b2ea4-9b9d-4147-8aa0-7313d6be2cfa2025-07-15WarningsExact identifier
unii: 88AYB867L5
sunmark triple antibiotic plus pain reliefPOLYMYXIN B SULFATE, BACITRACIN ZINC, NEOMYCIN SULFATE, AND PRAMOXINE HYDROCHLORIDEStrategic Sourcing Services LLC941a6a71-e898-4af3-989a-6d3aa32243382025-07-15WarningsExact identifier
unii: 88AYB867L5
TopCare Triple Antibiotic Plus Pain ReliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDETopco Associates LLC0fc0dbc6-ca1d-42be-8016-68e64f1197062025-07-15WarningsExact identifier
unii: 88AYB867L5
Triple Antibiotic Plus Pain ReliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDEWalgreen Companye2b7fc5b-c796-4ed1-aea7-4c810df250d52025-07-15WarningsExact identifier
unii: 88AYB867L5

Reported adverse events (FAERS/openFDA)#

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