Home NDC 63868-980 Sterile Alcohol
Product NDC 63868-980
11-digit product format 638680980
Labeler code 63868
Product ID 63868-980_2ad55938-0101-3a3f-e063-6394a90af7f5
Type HUMAN OTC DRUG
Nonproprietary name Isopropyl alcohol
Dosage form SWAB
Route TOPICAL
Labeler Chain Drug Marketing Association Inc
Application M003
Marketing category OTC MONOGRAPH DRUG
Marketing start 2013-06-30
Marketing end 2026-11-30
Substance ISOPROPYL ALCOHOL
Active strength .7 mL/1
NDC exclude flag No
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 18 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2024-11-09 02:27 UTC · source 2024-11-08 excluded product product I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 63868-980-01 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 63868-980-01 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 63868-980-01 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 63868-980-01 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 63868-980-01 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 63868-980-01 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 63868-980-01 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 63868-980-01 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 63868-980-01 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Sterile Alcohol Active Ingredients# Ingredient, Strength table Ingredient Strength ISOPROPYL ALCOHOL .7 mL/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination ND2M416302 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 797544 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63868-980-01 Sterile Alcohol 1 in 1 PACKET SWAB 1 8 63868-980-01 Sterile Alcohol 100 in 1 BOX SWAB 100 8
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63868-980 STERILE ALCOHOL (ISOPROPYL ALCOHOL) SWAB [CHAIN DRUG MARKETING ASSOCIATION INC] 8 Current NDC, Legacy NDC, 2 package rows 20250105_55922632-3768-4450-9389-ba7d7d91f2c9.zip
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 92 of 114 · 2,277 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join germstarCitrus ETHYL ALCOHOL Soaptronic, LLC 779abef7-53ff-47c3-b7e6-27570eb055b3 2024-12-19 Warnings Exact identifier application number: M003 germstarGel ETHYL ALCOHOL Soaptronic, LLC b5fd6c3c-d452-74e6-e053-2995a90a9090 2024-12-19 Warnings Exact identifier application number: M003 Isopropyl alcohol 91 percent ISOPROPYL ALCOHOL Jell Pharmaceuticals Pvt. Ltd. cd98812b-017a-2cd2-e053-2a95a90a38ce 2024-12-18 Warnings Exact identifier application number: M003 Isopropyl Rubbing Alcohol 50% ISOPROPYL ALCOHOL MY IMPORTS LLC d4d72406-067d-1f67-e053-2995a90a1a9f 2024-12-18 Warnings Exact identifier application number: M003 AMORAY 70% ISOPROPYL RUBBING ALCOHOL ISOPROPYL ALCOHOL MY IMPORT USA INC 7114b527-106b-4629-867c-63dba13635a2 2024-12-18 Warnings Exact identifier application number: M003 AMERICAN REDCROSS 70% ISOPROPYL RUBBING ALCOHOL WITH WINTERGREEN ISOPROPYL ALCOHOL MY IMPORTS USA LLC d4d7e7f8-7c8a-2b51-e053-2995a90a63d0 2024-12-18 Warnings Exact identifier application number: M003 ISOPROPYL RUBBING ALCOHOL 50% WITH WINTERGREEN ISOPROPYL ALCOHOL My Imports USA, LLC d4d77ec3-4930-74f0-e053-2a95a90a962a 2024-12-18 Warnings Exact identifier application number: M003 91% Isopropyl Rubbing Alcohol ISOPROPYL ALCOHOL MY IMPORTS USA LLC d4d7adaf-c0fd-82fa-e053-2995a90ab9f6 2024-12-18 Warnings Exact identifier application number: M003 ISOPROPYL RUBBING ALCOHOL 50% WITH WINTERGREEN ISOPROPYL ALCOHOL MY IMPORTS USA, LLC de47bf08-f64e-781d-e053-2a95a90ab08f 2024-12-18 Warnings Exact identifier application number: M003 AMERICAN REDCROSS 91% ISOPROPYL RUBBING ALCOHOL WITH WINTERGREEN ISOPROPYL ALCOHOL MY IMPORTS USA LLC d4d80ae4-3fba-4605-e053-2a95a90a2119 2024-12-18 Warnings Exact identifier application number: M003 American Red Cross 50% Isopropyl Rubbing Alcohol ISOPROPYL ALCOHOL MY IMPORTS USA LLC de47a879-9cd0-5fbb-e053-2a95a90a1fba 2024-12-18 Warnings Exact identifier application number: M003 RUBBING ALCOHOL ALCOHOL INTERNATIONAL GENERAL TRADING CORP bd5ee961-1d64-0d9d-e053-2a95a90a6010 2024-12-18 Warnings Exact identifier application number: M003 70% Isopropyl Rubbing Alcohol ISOPROPYL ALCOHOL SZY Holdings, LLC dba EverReady First Aid 1e39b0f4-66d1-47ac-aed6-d6ac019888ce 2024-12-18 Warnings Exact identifier application number: M003 RUBBING ALCOHOL ALCOHOL INTERNATIONAL GENERAL TRADING CORP bd5eb0df-cd2d-691c-e053-2995a90a2511 2024-12-18 Warnings Exact identifier application number: M003 Isopropyl Rubbing Alcohol 70% ISOPROPYL ALCOHOL First Aid Research Corp. 7d1c0382-31b3-48d0-a514-c5cc45a2299e 2024-12-18 Warnings Exact identifier application number: M003 First Aid Only First Aid-Burn BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE Acme United Corporation f31a44ff-e4ac-de1e-e053-2a95a90ab036 2024-12-18 Warnings Exact identifier application number: M003 Hand Sanitizer (Lavender Rosemary) HAND SANITIZER SPRAY Tubby Todd 2992a52a-21a9-18be-e063-6294a90a834d 2024-12-18 Warnings Exact identifier application number: M003 CVS Decolorized Iodine ALCOHOL CVS Pharmacy d9f1a1aa-f402-4c0d-96e8-eeb5eb5cfacd 2024-12-18 Warnings Exact identifier application number: M003 De La Cruz Decolorized Iodine ETHYL ALCOHOL DLC Laboratories, Inc. 5d8f6aaa-0b87-1166-e053-2991aa0a297f 2024-12-18 Warnings Exact identifier application number: M003 Humco Povidone Iodine POVIDONE IODINE 10% Humco Holding Group, Inc. 1e078022-f32c-48bd-8add-f83aebcc5812 2024-12-18 Warnings Exact identifier application number: M003
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 63868-980-01 63868098001 100 PACKET in 1 BOX (63868-980-01) / 1 SWAB in 1 PACKET 100 packet 2017-03-10 2026-11-30 No No Current