FDA.reportPublic FDA data

NDC 58463-013-20 - KEFLEX

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
58463-013
Requested NDC
58463-013-20
Package NDCs from labels
58463-013-50, 58463-013-20
Manufacturer
Pragma Pharmaceuticals, LLC
Effective date
2021-05-12
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
KEFLEX - Pragma Pharmaceuticals, LLCPragma Pharmaceuticals, LLC2021-05-12HUMAN PRESCRIPTION DRUG LABEL

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58463-013-50EA - Each58463-01325d48374-1fa5-419d-becc-648f4e32818c12016-05-16

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 4 of 144 · 2,878 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CVS PHARMACY Extra StrengthSIMETHICONECVS98db6216-897c-4cf6-a4b7-b913ae3a24962026-08-13WarningsExact identifier
unii: 92RU3N3Y1O
CVS PHARMACY Gas reliefSIMETHICONECVSc2a3a978-c957-4453-88b3-53f4e80a24652026-08-13WarningsExact identifier
unii: 92RU3N3Y1O
CephalexinCEPHALEXINPreferred Pharmaceuticals Inc.864d2046-b2c8-415c-814b-512bc4901c762026-08-12Warnings, Adverse reactionsExact identifier
unii: OBN7UDS42Y
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30DR. SAMRAO'S OFFICE58b2ca35-11ed-d848-e063-6294a90a5b372026-08-11WarningsExact identifier
unii: 15FIX9V2JP
Journee Firm Riche Broad Spectrum Sunscreen SPF 30TITANIUM DIOXIDE AND ZINC OXIDEMerz North America, Inc.d4d4bfcf-3674-4847-8ad8-1716a8e821ae2026-08-10WarningsExact identifier
unii: 15FIX9V2JP
WinCo FOODS Extra Strength Gas ReliefSIMETHICONEWINCO FOODS, LLCe2caf17a-a807-47f6-ab85-8e15a4679db42026-08-07WarningsExact identifier
unii: 92RU3N3Y1O
CephalexinCEPHALEXINREMEDYREPACK INC.c600a2c0-42ab-4be8-b9b1-59ba39494b3f2026-08-07Warnings, Adverse reactionsExact identifier
unii: OBN7UDS42Y
CephalexinCEPHALEXINPD-Rx Pharmaceuticals, Inc.af3e9919-3812-4917-bb6e-266a692ee4ab2026-08-07Warnings, Adverse reactionsExact identifier
unii: OBN7UDS42Y
CephalexinCEPHALEXINPD-Rx Pharmaceuticals, Inc.a24a3c7c-c0f8-4107-ab30-751bea743d2d2026-08-07Warnings, Adverse reactionsExact identifier
unii: OBN7UDS42Y
Extra Strength Gas ReliefSIMETHICONEShield Pharmaceuticals Corp55952af9-c3c1-452f-82c8-06f01dc4f0af2026-08-07WarningsExact identifier
unii: 92RU3N3Y1O
CephalexinCEPHALEXINPD-Rx Pharmaceuticals, Inc.3dc725a0-6e4b-45c6-9569-34ef654558452026-08-07Warnings, Adverse reactionsExact identifier
unii: OBN7UDS42Y
CephalexinCEPHALEXINPD-Rx Pharmaceuticals, Inc.e4e1ebcf-b43b-4dbe-9295-eeef67ba62722026-08-07Warnings, Adverse reactionsExact identifier
unii: OBN7UDS42Y
VEIRFOO Brightening Hydrating Antiwrinkle SunscreenTITANIUM DIOXIDE, OCTINOXATELCM TECHNOLOGY Co., Ltd4cbbf8aa-8910-b7e7-e063-6294a90a4f072026-08-07WarningsExact identifier
unii: 15FIX9V2JP
CephalexinCEPHALEXINREMEDYREPACK INC.b73593ce-0b1f-4371-bae1-140742de3b422026-08-06Warnings, Adverse reactionsExact identifier
unii: OBN7UDS42Y
AMAZON EXTRA STRENGTHSIMETHICONEAMAZON.COM SERVICES LLC705489ce-ac7c-44a8-8298-ead19824582e2026-08-06WarningsExact identifier
unii: 92RU3N3Y1O
EltaMD UV RestoreTITANIUM DIOXIDE, ZINC OXIDE SUNSCREENCP Skin Health Group, Inc37fee381-ce6b-4949-9a4a-778aa839fb842026-08-06WarningsExact identifier
unii: 15FIX9V2JP
Gencare-Gas ReliefSIMETHICONE 180 MGPIONEER LIFE SCIENCES, LLCb7f2d5db-c1b7-4c01-8ee6-017e4b9f14252026-08-04WarningsExact identifier
unii: 92RU3N3Y1O
Luxe Gloss Hydrating Lip Gloss SPF 35-NAKED HONEYOCTOCRYLENE 8%, OCTISALATE 5%, TITANIUM DIOXIDE 6%, ZINC OXIDE 8%Lale Cosmetics LLC581fb0cd-c55d-d562-e063-6394a90a7f112026-08-03WarningsExact identifier
unii: 15FIX9V2JP
CephalexinCEPHALEXINREMEDYREPACK INC.d3527c0a-94e4-46a2-be77-d936abcd19ec2026-08-03Warnings, Adverse reactionsExact identifier
unii: OBN7UDS42Y
EltaMD UV ActiveZINC OXIDE AND TITANIUM DIOXIDE SUNSCREENCP Skin Health Group, Inc39d16479-d491-4c19-aa11-674461687c7b2026-08-03WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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