FDA.reportPublic FDA data

Hemorrhoid Anesthetic

Product NDC
52000-028
Requested package NDC
52000-028-37
11-digit product format
520000028
Labeler code
52000
Product ID
52000-028_d8870c0f-85ea-e5d9-e053-2a95a90a4489
Type
HUMAN OTC DRUG
Nonproprietary name
Mineral Oil, Petrolatum, Phenylephrine HCL
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Universal Distribution Center LLC
Application
part346
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2016-08-05
Marketing end
0000-00-00
Substance
MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE
Active strength
0 g/g; g/g; g/g
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage52000-02852000-028-37IInactivated 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 · 5 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2021-12-27 23:28 UTC · source 2021-12-278dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-109bebd1f3094a…5416666fcb17…

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
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52000-028-372025-07-29C16284748780-19d75b9d1-2781-f424-e053-dadaa90a57ceHemorrhoid Anesthetic Ointment
52000-028-372022-02-21C16284748780-19d75b9d1-2781-f424-e053-dadaa90a57ceHemorrhoid Anesthetic Ointment
52000-028-372020-01-31C16284748780-19d75b9d1-2781-f424-e053-dadaa90a57ceHemorrhoid Anesthetic Ointment

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52000-028-37Hemorrhoid Anesthetic1 in 1 CARTONOINTMENT14
52000-028-39Hemorrhoid Anesthetic28 g in 1 TUBEOINTMENT284

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52000-028HEMORRHOID ANESTHETIC (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [UNIVERSAL DISTRIBUTION CENTER LLC]4Legacy NDC, 2 package rows20241212_3955ed28-e2b5-1695-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1372298mineral oil 14 % / petrolatum 74.9 % / phenylephrine HCl 0.25 % Rectal OintmentPSN3955ed28-e2b5-1695-e054-00144ff8d46c4
1372298mineral oil 0.14 MG/MG / petrolatum 0.749 MG/MG / phenylephrine hydrochloride 0.0025 MG/MG Rectal OintmentSCD3955ed28-e2b5-1695-e054-00144ff8d46c4
1372298mineral oil 14 % / petrolatum 74.9 % / phenylephrine hydrochloride 0.25 % Rectal OintmentSY3955ed28-e2b5-1695-e054-00144ff8d46c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52000-028-37520000028371 TUBE in 1 CARTON (52000-028-37) > 28 g in 1 TUBE (52000-028-39) 1 tube2016-08-050000-00-00NoNoCurrent