FDA.reportPublic FDA data

astonea

Product NDC
77338-305
11-digit product format
773380305
Labeler code
77338
Product ID
77338-305_1bbae087-0d0a-67d2-e063-6294a90a8320
Type
HUMAN OTC DRUG
Nonproprietary name
Hydrocortisone
Dosage form
CREAM
Route
TOPICAL
Labeler
ASTONEA LABS PRIVATE LIMITED
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-05-02
Substance
HYDROCORTISONE ACETATE
Active strength
10 mg/g
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
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 · 12 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage77338-305-038af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage77338-305-028af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage77338-305-068af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage77338-305-03834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage77338-305-02834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage77338-305-06834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage77338-305-031332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage77338-305-021332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage77338-305-061332a3947898…d4bfe170f9cd…

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
astonea
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROCORTISONE ACETATE10 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3X7931PO74Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1043690Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
de09e859-c5fd-0cc5-e053-2a95a90a147eAvailable 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
77338-305-022024-06-25ASTONEA Hydrocortisone
77338-305-032024-06-25ASTONEA Hydrocortisone
77338-305-062024-06-25ASTONEA Hydrocortisone
77338-305-022024-01-30ASTONEA Hydrocortisone
77338-305-032024-01-30ASTONEA Hydrocortisone
77338-305-062024-01-30ASTONEA Hydrocortisone

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77338-305-02astonea0.9 g in 1 PACKETCREAM0.94
77338-305-03astonea28.3 g in 1 TUBECREAM28.34
77338-305-06astonea454 g in 1 JARCREAM4544

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77338-305ASTONEA (HYDROCORTISONE) CREAM [ASTONEA LABS PRIVATE LIMITED]4Current NDC, Legacy NDC, 3 package rows20240627_de09e859-c5fd-0cc5-e053-2a95a90a147e.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 145 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
INTIMALE Maximum Strength DelayLIDOCAINE HYDROCHLORIDESKINS SEXUAL HEALTH LIMITED25b9ade3-72b0-4b86-8c48-90310a26806f2023-11-11WarningsExact identifier
application number: M017
POWERECT Max Power Male DelayLIDOCAINE HYDROCHLORIDESKINS SEXUAL HEALTH LIMITED25a1c926-9543-44a7-865e-a4b6e1a40cbe2023-11-11WarningsExact identifier
application number: M017
SKINS DELAY Maximum Strength LidocaineLIDOCAINE HYDROCHLORIDESKINS SEXUAL HEALTH LIMITED172efe5d-28b8-443c-b3f9-4296691890812023-11-11WarningsExact identifier
application number: M017
GASPARI Ageless Pain Relief CreamMENTHOLGASPARI ANTI-AGING LLCea806089-688b-4944-ad69-86f366509eb52023-11-11WarningsExact identifier
application number: M017
ZENSEZONE Arthmed Temporary Pain Relief CreamCAPSAICIN, MENTHOL, METHYL SALICYLATEZENSEZONE LLCc5778f22-c411-4bd7-b2af-45e3fee15fd22023-11-11WarningsExact identifier
application number: M017
PRFC HEMP Topical AnalgesicMENTHOLDOBEST INC722da9d1-91d7-45be-adb1-8d6a22aa83ac2023-11-11WarningsExact identifier
application number: M017
AMP RELIEF Pain Relief CreamMENTHOLCOASTAL FORMULAS LLC84ea496e-ab54-4882-93ef-600f8eb33cb42023-11-11WarningsExact identifier
application number: M017
AMP RELIEF Pain Relief CreamMENTHOLCOASTAL FORMULAS LLC39564c67-49ab-42d4-a391-792ac69180c02023-11-11WarningsExact identifier
application number: M017
LIDOSOLVE PAIN RELIEFLIDOCAINE HYDROCHLORIDEHENNIKA HEALTH, LLC3a9e4e0c-362d-4e66-bb5f-984fe1c9d4e22023-11-11WarningsExact identifier
application number: M017
AMINO ACTIVE Topical Analgesic CreamHISTAMINE DIHYDROCHLORIDEVIREO SYSTEMS, INC.591b1e7e-a8c0-4640-a592-4e0f3538a40e2023-11-11WarningsExact identifier
application number: M017
NERVE ACTIVE Pain Relief CreamMENTHOLTOP DOG DIRECT, LLCa8b85dcb-fd3e-4340-a945-609fc741443c2023-11-11WarningsExact identifier
application number: M017
GeriGentle FrostyHeat Pain Relief Patch 4 Lodocaine BackLIDOCAINEGeri-Gentle Corporatione4427928-c063-9ca6-e053-2995a90a1aa12023-11-10WarningsExact identifier
application number: M017
GeriGentle FrostyHeat Pain Relief Patch Arm and NeckMENTHOLGeri-Gentle Corporatione4429f70-667e-662b-e053-2a95a90a62ba2023-11-10WarningsExact identifier
application number: M017
GeriGentle FrostyHeat Pain Relief Patch BackMENTHOLGeri-Gentle Corporatione442b8ec-a3de-65e8-e053-2995a90af3ec2023-11-10WarningsExact identifier
application number: M017
SUPER WHITE STUFF Pain ReliefMENTHOLBLUE SPRING WELLNESS, L.L.C.9f948fb4-4275-4a1f-83f8-cd708db4a2962023-11-10WarningsExact identifier
application number: M017
SUPER WHITE STUFF PAIN RELIEFMENTHOLBLUE SPRING WELLNESS, L.L.C.b4278b70-e9a6-4d1f-bbad-257fe437b86a2023-11-10WarningsExact identifier
application number: M017
BLUE SPRING Foot and Leg Comfort Cream with Pain ReliefMENTHOL, CAPSAICINBLUE SPRING WELLNESS, L.L.C.2f9cf514-48be-49ec-b424-0b228b4b874a2023-11-10WarningsExact identifier
application number: M017
SUPER WHITE STUFF Pain ReliefMENTHOLBLUE SPRING WELLNESS, L.L.C.1231ddd2-7661-45b2-ab15-32f7fdc078a82023-11-10WarningsExact identifier
application number: M017
SUPER WHITE Stuff Pain ReliefMENTHOLBLUE SPRING WELLNESS, L.L.C.7779b26b-ae3b-4639-a6b0-826c7ab37a862023-11-10WarningsExact identifier
application number: M017
Alo Therapeutic MassageMENTHOL, HISTAMINE DIHYDROCHLORIDETheraplex Solutionsa898d2ef-5fa0-4144-8bb5-f6d5fc3ff0d42023-11-10WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1043690hydrocortisone acetate 1 % Topical CreamPSNde09e859-c5fd-0cc5-e053-2a95a90a147e4
1043690hydrocortisone acetate 10 MG/ML Topical CreamSCDde09e859-c5fd-0cc5-e053-2a95a90a147e4
1043690hydrocortisone acetate 1 % Topical CreamSYde09e859-c5fd-0cc5-e053-2a95a90a147e4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
77338-305-0277338030502.9 g in 1 PACKET (77338-305-02) 2022-05-020000-00-00NoNoCurrent
77338-305-037733803050328.3 g in 1 TUBE (77338-305-03) 28.3 g2022-05-020000-00-00NoNoCurrent
77338-305-0677338030506454 g in 1 JAR (77338-305-06) 454 g2022-05-020000-00-00NoNoCurrent