FDA.reportPublic FDA data

Alcohol

Product NDC
41163-816
11-digit product format
411630816
Labeler code
41163
Product ID
41163-816_5aaecb69-42f2-288b-e063-6394a90a48a2
Type
HUMAN OTC DRUG
Nonproprietary name
Isopropyl Alcohol
Dosage form
SWAB
Route
TOPICAL
Labeler
SuperValu, Inc.
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2011-04-06
Substance
ISOPROPYL ALCOHOL
Active strength
70 mL/100mL
NDC exclude flag
No
Listing certified through
2027-12-31
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 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage41163-816-30e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage41163-816-309bebd1f3094a…5416666fcb17…

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
Alcohol
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ISOPROPYL ALCOHOL70 mL/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
ND2M416302Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
797544Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5e6e6d6f-4472-40f1-b0a9-96cee7ef075bAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2021-12-0841163-816 SuperValu Equaline IPA prep pads
2021-12-0841163-816 SuperValu Equaline IPA prep pads
2020-01-3141163-816 SuperValu Equaline IPA prep pads
2020-01-3141163-816 SuperValu Equaline IPA prep pads

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41163-816-30Alcohol1 in 1 PACKETSWAB17
41163-816-30Alcohol100 in 1 BOXSWAB1007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
41163-816-30EA - Each41163-816b751b9ea-1a39-4ebe-b2fd-c2194ac81b1212024-04-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ISOPROPYL ALCOHOLACTIVE INGREDIENTND2M416302ALCOHOL (ISOPROPYL ALCOHOL) SWAB [SUPERVALU, INC.]3
ISOPROPYL ALCOHOLACTIVE MOIETYND2M416302ALCOHOL (ISOPROPYL ALCOHOL) SWAB [SUPERVALU, INC.]3
WATERINACTIVE INGREDIENT059QF0KO0RALCOHOL (ISOPROPYL ALCOHOL) SWAB [SUPERVALU, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41163-816ALCOHOL (ISOPROPYL ALCOHOL) SWAB [SUPERVALU, INC.]7Current NDC, Legacy NDC, 2 package rows20250105_5e6e6d6f-4472-40f1-b0a9-96cee7ef075b.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 114 of 114 · 2,270 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hand sanitizer 1.8oz with extra clip originalETHYL ALCOHOLRejoice International Corp.06da0cc1-95f2-4f88-e063-6394a90a25ea2023-10-03WarningsExact identifier
application number: M003
First Aid Antiseptic Alcohol Pads Isopropyl Alcohol 70 Rite AidISOPROPYL ALCOHOLRite Aid Corporationaa0df5fe-62d1-407d-b8f9-a7fd9473d5692023-10-02WarningsExact identifier
application number: M003
Foaming Instant Hand Sanitizer with AloeETHANOLMCKESSON MEDICAL-SURGICAL INC.5c1f69b7-c8d8-477c-b614-47a3287b0e4c2023-06-05WarningsExact identifier
application number: M003
Bactine Max DryLIDOCAINE HYDROCHLORIDEWellSpring Pharmaceutical Corporation466404cd-c46a-4944-b1ac-3b3b17f436a12022-12-27WarningsExact identifier
application number: M003
Povidone-Iodine PadPOVIDONE-IODINEShandong Haiyan Medical Manufacture Co., Ltd.c9187a07-92d5-15ac-e053-2995a90af4cb2022-03-19WarningsExact identifier
application number: M003
Alcohol Prep PadISOPROPYL ALCOHOLShandong Haiyan Medical Manufacture Co., Ltd.1a117840-22d0-4a88-b1a6-e43162a444ab2022-03-19WarningsExact identifier
application number: M003
FIRSTAR BZK Antiseptic ToweletteBENZALKONIUM CHLORIDEJIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.28591a97-9291-48c8-a8e3-c419180331b32021-07-06WarningsExact identifier
application number: M003
Bactine MaxBENZALKONIUM CHLORIDE AND LIDOCAINE HYDROCHLORIDEWellSpring Pharmaceutical Corporation28e8a311-20a4-45a1-8d5d-ca42b101c2752021-02-24WarningsExact identifier
application number: M003
Hand Sanitizer Lemon 2ozALCOHOLNingbo Rejoice Internationalb0a4159a-cb07-4ce6-e053-2995a90a76e72020-10-02WarningsExact identifier
application number: M003
Sanix Alcohol Hand RubALCOHOLTopiderm, Inca4fbb714-4f20-400a-ab98-f1c8807ce6fc2020-03-24WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
797544isopropyl alcohol 70 % Medicated PadPSN5e6e6d6f-4472-40f1-b0a9-96cee7ef075b7
797544isopropyl alcohol 0.7 ML/ML Medicated PadSCD5e6e6d6f-4472-40f1-b0a9-96cee7ef075b7
797544isopropyl alcohol 70 % Medicated PadSY5e6e6d6f-4472-40f1-b0a9-96cee7ef075b7
797544isopropyl alcohol 70 % Topical ClothSY5e6e6d6f-4472-40f1-b0a9-96cee7ef075b7
797544isopropyl alcohol 70 % Topical SwabSY5e6e6d6f-4472-40f1-b0a9-96cee7ef075b7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41163-816-3041163081630100 PACKET in 1 BOX (41163-816-30) / 1 APPLICATOR in 1 PACKET / 5 mL in 1 APPLICATOR100 packet2011-04-060000-00-00NoNoCurrent