FDA.reportPublic FDA data

Alocane Anti-Itch

Product NDC
68229-411
11-digit product format
682290411
Labeler code
68229
Product ID
68229-411_4b235f6d-d684-e3a3-e063-6294a90a02fa
Type
HUMAN OTC DRUG
Nonproprietary name
Hydrocortisone 1%
Dosage form
GEL
Route
TOPICAL
Labeler
Quest Products, LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-12-04
Substance
HYDROCORTISONE
Active strength
1 g/100g
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [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
Alocane Anti-Itch
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROCORTISONE1 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
WI4X0X7BPJInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198706Internal RxNorm lookup
2728413Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
45252043-d41a-3cdd-e063-6394a90aa9e5Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
15bd4439-874a-4934-9954-248e5455d460Product name120260310
9962b773-9f2e-22cc-0032-535e48ac417bProduct name320250724
56bb0587-1bf2-48b2-9d93-fc9f59d1eeb2Product name120250325
4d56e8eb-d741-d4a5-de3f-2bab1af75a60Product name720220608
626d7260-31b5-4412-84fd-579746adb6b3Product name120210513
8a011600-5e61-4c59-ab7b-54ab658a3b71Product name220181127
a919621a-248d-3c7a-1084-9f9ce286fdfdProduct name220181009
e7d5a174-836b-a0af-b014-cb0826c69ddcProduct name220181004
fcce390d-6460-4701-87cf-940d8800a1c3Product name220180212
bf065fa6-1e3b-e4c3-0bde-2dc842ceeea1Product name220150218
02657a3f-1489-66ea-f740-5ab9524e57d7Product name120140508
26f3d783-2cc1-4327-e77d-71804cf675a2Product name120140508
36fdc54c-bbeb-981e-8a53-4d768e283892Product name120140508
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
61e59a42-186b-9f4b-aec3-fb49a6debc31Product name120140508
705740e1-dee5-2610-c5a3-4c59cd9d62afProduct name120140508
7bdc4804-3832-c0df-e519-72b6d47c9792Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
abaf203f-619e-f265-559f-8c81af5cb1c2Product name120140508
acc4d8bb-0e29-e9f8-65f8-31e94184a9c0Product name120140508
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
bfd28ffb-d550-3fe9-f65b-10bcb7f971fdProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508
fe21f3fd-a378-0654-1972-db3c3b64470eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68229-411-01Alocane Anti-Itch70.8 g in 1 TUBEGEL70.82
68229-411-02Alocane Anti-Itch1 in 1 CARTONGEL12
68229-411-03Alocane Anti-Itch42.5 g in 1 TUBEGEL42.52
68229-411-04Alocane Anti-Itch1 in 1 CARTONGEL12

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 3 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Calamine PlusCALAMINE, PRAMOXINE HYDROCHLORIDEKroger Company44fdd5a4-3cac-15e5-e063-6294a90adb522026-08-26WarningsExact identifier
application number: M017
Lidocaine Pain ReliefLIDOCAINECardinal Health, 110 dba LEADER025d508b-ec4f-466c-b3e8-ba9b18d07b462026-08-26WarningsExact identifier
application number: M017
Inknows Lidocaine Pain Relief Gel-PatchLIDOCAINE PAIN RELIEF GEL-PATCHHenan Enokon Medical Instrument Co., Ltd.59eb9c12-9e00-0171-e063-6394a90a83422026-08-25WarningsExact identifier
application number: M017
LidomarLIDOMAROncora Pharma, LLC215bfdca-60bf-480b-b02e-902de52fe5e82026-08-25WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONEAmazon.com Services LLC5f87d7fb-f258-48b0-8b60-1055e22ebd712026-08-25WarningsExact identifier
application number: M017
HEEL PAIN RELIEF ROLL-ONLIDOCAINE AND MENTHOLGuangzhou Liuquanmiao Import & Export Trade Co., Ltd.59c7e13f-b9ea-023a-e063-6294a90a79e02026-08-24WarningsExact identifier
application number: M017
KNEE PAIN RELIEF ROLL-ONLIDOCAINE AND MENTHOLGuangzhou Liuquanmiao Import & Export Trade Co., Ltd.59c8b33a-7d4f-2c6e-e063-6394a90a79292026-08-24WarningsExact identifier
application number: M017
Bovonte Numbing CreamNUMBING CREAMGuangzhou Jingliang Cosmetics Co., Ltd.5958cc29-c449-56a7-e063-6394a90a960b2026-08-24WarningsExact identifier
application number: M017
HUSTLE BUTTER NUMBINGLIDOCAINE HYDROCHLORIDEH.B.D. D.I.S.T. INC.d7dfb312-6c80-4a2d-b8b2-d9891cb0b74e2026-08-24WarningsExact identifier
application number: M017
JELVOXA NECK PAIN RELIEVINGMENTHOLWuhan Ruihengjie Technology Co., Ltd.59a3d60a-26b5-e6a6-e063-6294a90a42bd2026-08-22WarningsExact identifier
application number: M017
JELVOXA DMSOCAMPHOR CAPSAICIN MENTHOLWuhan Ruihengjie Technology Co., Ltd.59a43e2c-d258-34b5-e063-6394a90a09bf2026-08-22WarningsExact identifier
application number: M017
Capsaicin 0.035 PercentCAPSAICINPreferred Pharmaceuticals Inc.0fabc025-4208-45f5-b3c2-543ae3a2df412026-08-21WarningsExact identifier
application number: M017
ClaravieHYDROCORTISONE ACETATEGentell LLC598d224b-d12e-89bf-e063-6394a90a84dc2026-08-21WarningsExact identifier
application number: M017
ETERNAL SPIRIT BEAUTY PAINLESS PAIN RELIEVINGMENTHOL, CAMPHORWorldwide Cosmetics, Inc3b8c2419-7a78-2731-e054-00144ff8d46c2026-08-21WarningsExact identifier
application number: M017
PARCHE FRIOMETHYL SALICYLATE, MENTHOL, AND CAMPHOR PATCHDW SUPPORT LLC5970a6f7-b273-9bb1-e063-6394a90afc792026-08-21WarningsExact identifier
application number: M017
Enokon Lidocaine Pain Relief PatchLIDOCAINE PAIN RELIEF PATCHHenan Enokon Medical Instrument Co., Ltd.5976e667-e506-1d11-e063-6394a90a68092026-08-20WarningsExact identifier
application number: M017
MQUPIN TIGER PatchTIGER PATCHZhengzhou Miaoqi Medical Technology Co., Ltd.5977cbb5-94c7-cb24-e063-6294a90a2e072026-08-20WarningsExact identifier
application number: M017
MQUPIN Nicotine PatchesNICOTINE PATCHESZhengzhou Miaoqi Medical Technology Co., Ltd.5978258a-549e-50e6-e063-6394a90a3d862026-08-20WarningsExact identifier
application number: M017
ClaravieCAMPHORGentell LLC5978bdab-5359-be9a-e063-6394a90a5a322026-08-20WarningsExact identifier
application number: M017
Rugby PAIN RELIEF PATCHESLIDOCAINERUGBY LABORATORIESb34e40c8-a257-46cf-9399-f55df9b4102d2026-08-20WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2728413ALOCANE Anti-Itch 1 % Topical GelPSN45252043-d41a-3cdd-e063-6394a90aa9e52
198706hydrocortisone 1 % Topical GelPSN45252043-d41a-3cdd-e063-6394a90aa9e52
2728413hydrocortisone 0.01 MG/MG Topical Gel [Alocane Anti-Itch]SBD45252043-d41a-3cdd-e063-6394a90aa9e52
198706hydrocortisone 0.01 MG/MG Topical GelSCD45252043-d41a-3cdd-e063-6394a90aa9e52
2728413Alocane Anti-Itch 1 % Topical GelSY45252043-d41a-3cdd-e063-6394a90aa9e52
198706hydrocortisone 1 % Topical GelSY45252043-d41a-3cdd-e063-6394a90aa9e52

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68229-411-016822904110170.8 g in 1 TUBE70.8 gHistorical
68229-411-02682290411021 TUBE in 1 CARTON (68229-411-02) / 70.8 g in 1 TUBE (68229-411-01) 1 tube2025-12-04NoNoCurrent
68229-411-036822904110342.5 g in 1 TUBE42.5 gHistorical
68229-411-04682290411041 TUBE in 1 CARTON (68229-411-04) / 42.5 g in 1 TUBE (68229-411-03) 1 tube2025-12-04NoNoCurrent