FDA.reportPublic FDA data

After Bite Xtra

Product NDC
44224-1276
11-digit product format
442241276
Labeler code
44224
Product ID
44224-1276_5ccc1abc-d46b-94ca-e063-6394a90a185f
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl
Dosage form
GEL
Route
TOPICAL
Labeler
Tender Corporation d/b/a Adventure Ready Brands
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-01-01
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
.4 g/20g
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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
After Bite Xtra
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE.4 g/20g

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44224-1276-0After Bite Xtra1 g in 1 TUBEGEL12
44224-1276-1After Bite Xtra1 in 1 BOXGEL12

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 72 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Family Care Anti-ItchHYDROCORTISONEUnited Exchange Corp.8e4d46d8-7084-0666-e053-2995a90ad5202025-10-21WarningsExact identifier
application number: M017
Coralite Pain ReliefCAMPHOR, MENTHOL, METHYL SALICYLATEUnited Exchange Corp.69aec845-3d4c-d226-e053-2991aa0afd122025-10-21WarningsExact identifier
application number: M017
WHITE FLOWER ANALGESIC BALMCAMPHOR, MENTHOL AND METHYL SALICYLATEHOE HIN PAK FAH YEOW MANUFACTORY LTDf3e3b8b5-b12b-49ac-9318-b0c358b136e92025-10-21WarningsExact identifier
application number: M017
Mountain Ice Sports RecoveryMENTHOLMountainside Medical Equipment, Inc.98638529-3c17-436e-901f-c8aea52bdab62025-10-20WarningsExact identifier
application number: M017
Lip Clear Lysine PlusMENTHOL, UNSPECIFIED FORMQuantum, Inc.21a5b4fb-baed-4766-9820-5c6051c147202025-10-20WarningsExact identifier
application number: M017
Buzz Away Sting SootheMENTHOLQuantum, Inc.419e34ea-17b2-ec32-e063-6394a90a603d2025-10-20WarningsExact identifier
application number: M017
Family Care Anti-ItchHYDROCORTISONEUnited Exchange Corp.deb09e89-9794-89a7-e053-2a95a90abdf82025-10-20WarningsExact identifier
application number: M017
Numbing CreamMENTHOLFlexiGo Inc41571c8f-332b-f423-e063-6394a90a88972025-10-20WarningsExact identifier
application number: M017
Soothing Nerve TherapyMENTHOLWise Consumer Products40829d6b-5005-7ec9-e063-6294a90a970e2025-10-20WarningsExact identifier
application number: M017
Numbing CreamMENTHOLFlexiGo Inc4146fd51-b18c-393d-e063-6294a90a4d9a2025-10-20WarningsExact identifier
application number: M017
Lidocaine 4% Maximum OTC StrengthLIDOCAINECardinal Health 107, LLC975031df-d46d-4098-b1c0-1c0c92b419952025-10-20WarningsExact identifier
application number: M017
Cortizone 10 Intensive HealingHYDROCORTISONEChattem, Inc.bb3d1a3e-4c0c-4694-9c05-80152dd9bd1c2025-10-20WarningsExact identifier
application number: M017
Sting relief padBENZOCAINE, ALCOHOLGuangdong Comfort Medical Products Co., Ltd.6e905065-10a9-1ded-e053-2a91aa0a46a12025-10-19WarningsExact identifier
application number: M017
CVS Cold and HotMENTHOLCVS Pharmacya44cec95-822a-40b6-e053-2995a90ae31c2025-10-17WarningsExact identifier
application number: M017
Sombra MaxSOMBRA MAXSombra Cosmetics Inc.41623a46-e6e7-907e-e063-6394a90afc4c2025-10-17WarningsExact identifier
application number: M017
POMADA DRAGON PAIN RELIEVINGCAMPHOR (SYNTHETIC), MENTHOL, METHYL SALICYLATETELEVISA CONSUMER PRODUCTS USAc283291d-feaa-4f89-8fde-9e3957ea8b9f2025-10-17WarningsExact identifier
application number: M017
Ear Pain MDLIDOCAINE HYDROCHLORIDEEosera Inc78c4418f-7f0f-447f-a94f-d4c89a081af12025-10-17WarningsExact identifier
application number: M017
WOFANLI Quit Smoking Nicotine PatchesNICOTINE TRANSDERMAL PATCHESShenzhen Paxi Trading Co., Ltd.414217c1-ff3a-b556-e063-6394a90aa5db2025-10-16WarningsExact identifier
application number: M017
WOFANLI Quit Smoking Nicotine PatchesNICOTINE TRANSDERMAL PATCHESShenzhen Paxi Trading Co., Ltd.41422d04-160b-51b2-e063-6294a90ab2b22025-10-16WarningsExact identifier
application number: M017
WOFANLI Quit Smoking Nicotine PatchesNICOTINE TRANSDERMAL PATCHESShenzhen Paxi Trading Co., Ltd.41427275-4c35-bbdf-e063-6294a90a14cf2025-10-16WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049880diphenhydrAMINE HCl 2 % Topical GelPSN22b8b83e-66d6-0caa-e063-6394a90ad6fd2
1049880diphenhydramine hydrochloride 0.02 MG/MG Topical GelSCD22b8b83e-66d6-0caa-e063-6394a90ad6fd2
1049880diphenhydramine hydrochloride 2 % Topical GelSY22b8b83e-66d6-0caa-e063-6394a90ad6fd2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
44224-1276-0442241276001 g in 1 TUBE1 gHistorical
44224-1276-1442241276011 TUBE in 1 BOX (44224-1276-1) / 1 g in 1 TUBE (44224-1276-0) 1 tube2025-01-01NoNoCurrent