SprinJene

Product NDC
63404-0720
Requested package NDC
63404-0720-2
11-digit product format
634040720
Labeler code
63404
Product ID
63404-0720_6a6f35e1-8954-4348-842c-1b9bcc500228
Type
HUMAN OTC DRUG
Nonproprietary name
ALCOHOL
Dosage form
GEL
Route
TOPICAL
Labeler
Health and Natural Beauty USA Corp
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-08-01
Substance
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 · 18 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-0886f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01bd6a592717d7…303034d00443…

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
SprinJene
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALCOHOL70 mL/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3K9958V90MInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
581662Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1853f023-f4db-4cd8-a4df-a439bc306cc3Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63404-0720-1SprinJene500 mL in 1 BOTTLE, PUMPGEL5001
63404-0720-2SprinJene300 mL in 1 BOTTLE, PUMPGEL3001
63404-0720-3SprinJene250 mL in 1 BOTTLE, PUMPGEL2501
63404-0720-4SprinJene80 mL in 1 BOTTLE, PUMPGEL801

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63404-0720SPRINJENE (ALCOHOL) GEL [HEALTH AND NATURAL BEAUTY USA CORP]1Current NDC, Legacy NDC, 4 package rows20200801_1853f023-f4db-4cd8-a4df-a439bc306cc3.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 74 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Isopropyl AlcoholISOPROPYL ALCOHOLSafeway, Inc.502b09be-b7e6-4ad7-be17-4c8b0e93b4ab2025-07-07WarningsExact identifier
application number: M003
Signature Select isopropyl alcohol wipesALCOHOLYiwu Yangjie Daily Chemicals Co.,Ltd.97272c57-88f0-40d9-b11f-d53cb806ee732025-07-04WarningsExact identifier
application number: M003
Universal 70% Rubbing Alcohol with Wintergreen and GlycerinUNIVERSAL 70% RUBBING ALCOHOL WITH WINTERGREEN AND GLYCERIN - ISOPROPYL ALCOHOL LIQUIDTSM BRANDS LLC390c6afd-e2c2-414c-e063-6294a90ae1192025-07-03WarningsExact identifier
application number: M003
RUBBING ALCOHOL 50 PERCENT WINTERGREENISOPROPYL ALCOHOLViny Health and Beauty Products Inc4b83f562-7ec7-72f3-e063-6294a90aba4d2025-07-01WarningsExact identifier
application number: M003
RUBBING ALCOHOL 50 PERCENTISOPROPYL ALCOHOLViny Health and Beauty Products Inc4b83e678-b79f-6dd6-e063-6294a90ad09d2025-07-01WarningsExact identifier
application number: M003
RUBBING ALCOHOL 70 PERCENTISOPROPYL ALCOHOLViny Health and Beauty Products Inc4babe369-3a35-34b5-e063-6394a90a68322025-07-01WarningsExact identifier
application number: M003
HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd38c323e2-9a9a-f898-e063-6394a90aa2262025-06-30WarningsExact identifier
application number: M003
UNIVERSAL ISOPROPYL RUBBING ALCOHOL 70% - isopropyl alcohol liquidUNIVERSAL ISOPROPYL RUBBING ALCOHOL 70% - ISOPROPYL ALCOHOL LIQUIDTSM BRANDS LLC38d03665-6e76-c76f-e063-6294a90a9e332025-06-30WarningsExact identifier
application number: M003
HAND SANITIZER FRESH LINENALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd322e492b-0690-a345-e063-6294a90aef2c2025-06-29WarningsExact identifier
application number: M003
HAND SANITIZER VANILLAALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd322e98dd-22ec-d4a3-e063-6394a90a80fa2025-06-29WarningsExact identifier
application number: M003
HAND SANITIZER STRAWBERRY FIZZALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd322e3045-14dc-ac2e-e063-6394a90a9b8a2025-06-29WarningsExact identifier
application number: M003
HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd38b857ee-760c-e98b-e063-6294a90a7c592025-06-29WarningsExact identifier
application number: M003
HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd38b857ee-760e-e98b-e063-6294a90a7c592025-06-29WarningsExact identifier
application number: M003
HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd38b87b19-7663-d5c5-e063-6294a90a9e872025-06-29WarningsExact identifier
application number: M003
Smart Care Assorted Hand Sanitizer -Passion FruitALCOHOLShenzhen Lantern Scicence Co.,Ltd.38895b60-f5a8-880f-e063-6394a90aa7062025-06-27WarningsExact identifier
application number: M003
Smart Care Assorted Hand Sanitizer -HibiscusALCOHOLShenzhen Lantern Scicence Co.,Ltd.3889d467-b179-bac4-e063-6394a90a61562025-06-27WarningsExact identifier
application number: M003
Smart Care Assorted Hand Sanitize -Cucumber MelonALCOHOLShenzhen Lantern Scicence Co.,Ltd.388a975c-b0b6-b80e-e063-6294a90a18142025-06-27WarningsExact identifier
application number: M003
Smart Care Assorted Hand Sanitizer -Sweet CitrusALCOHOLShenzhen Lantern Scicence Co.,Ltd.388abca3-12fb-449a-e063-6394a90aea982025-06-27WarningsExact identifier
application number: M003
First Aid AntisepticPOVIDONE-IODINERugby Laboratoriesb2bcb69e-8ffb-23ee-e053-2995a90aee212025-06-27WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer - Caramel HoneyALCOHOLShenzhen Lantern Scicence Co.,Ltd.3874c203-2c8b-79b3-e063-6294a90aedfb2025-06-26WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
581662ethanol 70 % Topical GelPSN1853f023-f4db-4cd8-a4df-a439bc306cc31
581662ethanol 0.7 ML/ML Topical GelSCD1853f023-f4db-4cd8-a4df-a439bc306cc31
581662ethanol 70 % Topical GelSY1853f023-f4db-4cd8-a4df-a439bc306cc31
581662ethyl alcohol 70 % Topical GelSY1853f023-f4db-4cd8-a4df-a439bc306cc31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63404-0720-263404072002300 mL in 1 BOTTLE, PUMP (63404-0720-2) 300 ml2020-08-010000-00-00NoNoCurrent