FDA.reportPublic FDA data

HEMORRHOIDALCREAMPro

Product NDC
77338-410
11-digit product format
773380410
Labeler code
77338
Product ID
77338-410_efbc30cb-2d87-6f8e-e053-2a95a90ad41b
Type
HUMAN OTC DRUG
Nonproprietary name
Phenylephrine HCl, Petrolatum, Mineral Oil
Dosage form
CREAM
Route
TOPICAL
Labeler
ASTONEA LABS PRIVATE LIMITED
Application
part346
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2022-10-05
Marketing end
0000-00-00
Substance
MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE
Active strength
14 g/100g; g/100g; g/100g
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct77338-410IInactivated by FDA2026-10-05
excluded packagepackage77338-41077338-410-55IInactivated 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 · 6 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 packagepackage77338-410-558af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage77338-410-55834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage77338-410-551332a3947898…d4bfe170f9cd…

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
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77338-410-552024-06-25C16284748780-11030e365-4b0d-111a-e063-dadaa90a10e2Astonea Hemorrhoidal Cream
77338-410-552024-01-30C16284748780-11030e365-4b0d-111a-e063-dadaa90a10e2Astonea Hemorrhoidal Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77338-410-55HEMORRHOIDALCREAMPro56.6 g in 1 TUBECREAM56.64

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77338-410HEMORRHOIDALCREAMPRO (PHENYLEPHRINE HCL, PETROLATUM, MINERAL OIL) CREAM [ASTONEA LABS PRIVATE LIMITED]4Legacy NDC, 1 package rows20240627_e9c32d81-cd9d-4ff2-e053-2995a90aa499.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
77338-410-557733804105556.6 g in 1 TUBE (77338-410-55) 56.6 g2022-10-050000-00-00NoNoCurrent