FDA.reportPublic FDA data

After Bite Xtra

Product NDC
90107-1270
Requested package NDC
90107-1270-1
11-digit product format
901071270
Labeler code
90107
Product ID
90107-1270_af965c5c-072b-569f-e053-2995a90a017e
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl
Dosage form
GEL
Route
TOPICAL
Labeler
Adventure Ready Brands
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-09-01
Marketing end
0000-00-00
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
20 mg/g
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage90107-127090107-1270-1IInactivated by FDA2026-10-05

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 · 9 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
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.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
90107-1270-02026-01-29After Bite Xtra
90107-1270-12026-01-29After Bite Xtra
90107-1270-02024-12-27After Bite Xtra
90107-1270-12024-12-27After Bite Xtra
90107-1270-02022-01-28After Bite Xtra
90107-1270-12022-01-28After Bite Xtra

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
90107-1270-0After Bite Xtra20 g in 1 TUBEGEL202
90107-1270-1After Bite Xtra20 g in 1 TUBEGEL202
90107-1270-1After Bite Xtra1 in 1 BOXGEL12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
90107-1270AFTER BITE XTRA (DIPHENHYDRAMINE HCL) GEL [ADVENTURE READY BRANDS]2Legacy NDC, 3 package rows20241228_af965c5c-072a-569f-e053-2995a90a017e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049880diphenhydrAMINE HCl 2 % Topical GelPSNaf965c5c-072a-569f-e053-2995a90a017e2
1049880diphenhydramine hydrochloride 0.02 MG/MG Topical GelSCDaf965c5c-072a-569f-e053-2995a90a017e2
1049880diphenhydramine hydrochloride 2 % Topical GelSYaf965c5c-072a-569f-e053-2995a90a017e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
90107-1270-1901071270011 TUBE in 1 BOX (90107-1270-1) > 20 g in 1 TUBE1 tube2020-09-010000-00-00NoNoCurrent