FDA.reportPublic FDA data

NDC 80425-0416-01 - CLINDAMYCIN HYDROCHLORIDE

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
80425-0416
Requested NDC
80425-0416-01
Package NDCs from labels
80425-0416-3, 80425-0416-1, 80425-0416-2, 80425-0416-01
Manufacturer
Advanced Rx of Tennessee, LLC
Effective date
2024-07-16
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
CLINDAMYCIN HYDROCHLORIDE - Advanced Rx of Tennessee, LLCAdvanced Rx of Tennessee, LLC2024-07-16HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0416-1CLINDAMYCIN HYDROCHLORIDE21 in 1 BOTTLECAPSULE211
80425-0416-2CLINDAMYCIN HYDROCHLORIDE28 in 1 BOTTLECAPSULE281
80425-0416-3CLINDAMYCIN HYDROCHLORIDE30 in 1 BOTTLECAPSULE301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0416CLINDAMYCIN HYDROCHLORIDE CAPSULE [ADVANCED RX OF TENNESSEE, LLC]1Current NDC, 3 package rows20240719_1d760cb7-d166-6707-e063-6394a90a8850.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0416-1EA - Each80425-04160fa40c31-dffe-4474-a8e1-f84db005b87812024-08-12
80425-0416-2EA - Each80425-0416dea651d1-d193-4027-9eb4-c89f0e9be6fd12024-08-12
80425-0416-3EA - Each80425-04169b734410-f232-4f5e-a7a8-7dda2bf7227b12024-08-12

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 9 of 282 · 5,628 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Zep Instant Hand Sanitizer GelALCOHOLZep Inc.b0ee8023-0128-56d6-e053-2a95a90ab4ed2026-08-13WarningsExact identifier
unii: 3K9958V90M
Zep Instant Hand Sanitizer GelALCOHOLZep Inc.b0ed98cd-871b-d862-e053-2995a90a14cc2026-08-13WarningsExact identifier
unii: 3K9958V90M
AFCO 5511 Sanifect E3ETHANOLZep Inc.34795eba-9ec4-6401-e063-6394a90af4282026-08-13WarningsExact identifier
unii: 3K9958V90M
Alcohol Hand SanitizerETHYL ALCOHOLGuangdong Yanze Biotechnology Co., Ltd.58fa90dc-c3b5-787b-e063-6294a90a2e172026-08-13WarningsExact identifier
unii: 3K9958V90M
WISH HAND SANITIZER Mango Coconut CreamALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA58faa781-520b-92fa-e063-6294a90a9ecf2026-08-13WarningsExact identifier
unii: 3K9958V90M
FRESH FEELS HAND SANITIZER MIST COCONUT VANILLA SCENTETHYL ALCOHOLAmber Glow Cosmetics Limited89dd227a-365f-4d8b-b21a-4f1c1b5c9c0a2026-08-13WarningsExact identifier
unii: 3K9958V90M
SprinJeneALCOHOLHealth and Natural Beauty USA Corp1853f023-f4db-4cd8-a4df-a439bc306cc32026-08-13WarningsExact identifier
unii: 3K9958V90M
Clindamycin hydrochlorideCLINDAMYCIN HYDROCHLORIDECardinal Health 107, LLCb22be885-f441-473e-879a-862588dcf89d2026-08-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: T20OQ1YN1W
FRESH FEELS HAND SANITIZER MIST WATERMELON POP SCENTETHYL ALCOHOLAmber Glow Cosmetics Limited3fea32bb-98ec-4dc6-97d3-c77d8e476c042026-08-13WarningsExact identifier
unii: 3K9958V90M
WhiskCare 373ALCOHOLWhisk Products, Inc.57d5cd5d-8597-ce66-e063-6394a90a00472026-08-12WarningsExact identifier
unii: 3K9958V90M
ZoviroALCOHOLZoviro, LLC9c8ca084-8aef-4616-8d51-aaff3eb253432026-08-12WarningsExact identifier
unii: 3K9958V90M
LUXURY IPA 70%LUXURY ISOPROPYL ALCOHOL 70% 16OZTSM BRANDS LLC2240a9e0-dac5-54fa-e063-6394a90a35f52026-08-11WarningsExact identifier
unii: ND2M416302
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30DR. SAMRAO'S OFFICE58b2ca35-11ed-d848-e063-6294a90a5b372026-08-11WarningsExact identifier
unii: 15FIX9V2JP
Aire-Master Foaming Hand Sanitizer Fragrance FreeALCOHOLWhisk Products, Inc.56a8f08e-7683-d155-e063-6394a90ac77b2026-08-11WarningsExact identifier
unii: 3K9958V90M
SYSTANE HYDRATION PF PRESERVATIVE FREEPOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.8936f66f-10fe-44ab-a26e-dd8b05dfa9972026-08-10WarningsExact identifier
unii: 6DC9Q167V3
Ethyl alcoholETHYL ALCOHOLStrategic Sourcing Services LLC4fec6f1f-0249-423f-bd3c-427aa6924c6f2026-08-10Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
MagiCare Premium Hand Sanitizing WipesALCOHOLMAGICARE TECH CORP3113dd38-257e-4b30-a611-1f259d1e3d1b2026-08-10WarningsExact identifier
unii: 3K9958V90M
Systane Pro PFPROPYLENE GLYCOLAlcon Laboratories, Inc.23b3515f-fbe5-4398-b2df-8b2eccdd01e22026-08-10WarningsExact identifier
unii: 6DC9Q167V3
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
B-Pure Moisturizing Hand Sanitizer, Orchid Vanilla ScentedALCOHOLFourstar Group USA, Inc.cca1b0ff-f8bd-4440-939e-de3fb7920c2d2026-08-07WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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