Anesthetic Hemorrhoidal

Product NDC
29500-2438
Requested package NDC
29500-2438-1
11-digit product format
295002438
Labeler code
29500
Product ID
29500-2438_ab1ce5cf-f5ca-05f4-e053-2995a90ae8ba
Type
HUMAN OTC DRUG
Nonproprietary name
PRAMOXINE HYDROCHLORIDE, ZINC OXIDE
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Personal Care Products, Inc.
Application
part347
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2013-07-10
Marketing end
0000-00-00
Substance
PRAMOXINE HYDROCHLORIDE; ZINC OXIDE
Active strength
420 mg/42g; g/42g
NDC exclude flag
No
Listing certified through
2021-12-31
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 packagepackage29500-243829500-2438-1IInactivated by FDA2026-10-12

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 · 19 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…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-0886f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01bd6a592717d7…303034d00443…
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
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
29500-2438-1Anesthetic HemorrhoidalWith Aloe42 g in 1 TUBEOINTMENT422

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PRAMOXINE HYDROCHLORIDEACTIVE INGREDIENT88AYB867L5ANESTHETIC HEMORRHOIDAL WITH ALOE (PRAMOXINE HYDROCHLORIDE, ZINC OXIDE) OINTMENT [PERSONAL CARE PRODUCTS, INC.]1
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54ZANESTHETIC HEMORRHOIDAL WITH ALOE (PRAMOXINE HYDROCHLORIDE, ZINC OXIDE) OINTMENT [PERSONAL CARE PRODUCTS, INC.]1
PRAMOXINEACTIVE MOIETY068X84E056ANESTHETIC HEMORRHOIDAL WITH ALOE (PRAMOXINE HYDROCHLORIDE, ZINC OXIDE) OINTMENT [PERSONAL CARE PRODUCTS, INC.]1
ZINC OXIDEACTIVE MOIETYSOI2LOH54ZANESTHETIC HEMORRHOIDAL WITH ALOE (PRAMOXINE HYDROCHLORIDE, ZINC OXIDE) OINTMENT [PERSONAL CARE PRODUCTS, INC.]1
BALSAM PERUINACTIVE INGREDIENT8P5F881OCYANESTHETIC HEMORRHOIDAL WITH ALOE (PRAMOXINE HYDROCHLORIDE, ZINC OXIDE) OINTMENT [PERSONAL CARE PRODUCTS, INC.]1
BENZYL BENZOATEINACTIVE INGREDIENTN863NB338GANESTHETIC HEMORRHOIDAL WITH ALOE (PRAMOXINE HYDROCHLORIDE, ZINC OXIDE) OINTMENT [PERSONAL CARE PRODUCTS, INC.]1
CALCIUM PHOSPHATEINACTIVE INGREDIENT97Z1WI3NDXANESTHETIC HEMORRHOIDAL WITH ALOE (PRAMOXINE HYDROCHLORIDE, ZINC OXIDE) OINTMENT [PERSONAL CARE PRODUCTS, INC.]1
COCOA BUTTERINACTIVE INGREDIENT512OYT1CRRANESTHETIC HEMORRHOIDAL WITH ALOE (PRAMOXINE HYDROCHLORIDE, ZINC OXIDE) OINTMENT [PERSONAL CARE PRODUCTS, INC.]1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4ANESTHETIC HEMORRHOIDAL WITH ALOE (PRAMOXINE HYDROCHLORIDE, ZINC OXIDE) OINTMENT [PERSONAL CARE PRODUCTS, INC.]1
GLYCERYL OLEATEINACTIVE INGREDIENT4PC054V79PANESTHETIC HEMORRHOIDAL WITH ALOE (PRAMOXINE HYDROCHLORIDE, ZINC OXIDE) OINTMENT [PERSONAL CARE PRODUCTS, INC.]1
KAOLININACTIVE INGREDIENT24H4NWX5COANESTHETIC HEMORRHOIDAL WITH ALOE (PRAMOXINE HYDROCHLORIDE, ZINC OXIDE) OINTMENT [PERSONAL CARE PRODUCTS, INC.]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPANESTHETIC HEMORRHOIDAL WITH ALOE (PRAMOXINE HYDROCHLORIDE, ZINC OXIDE) OINTMENT [PERSONAL CARE PRODUCTS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
29500-2438ANESTHETIC HEMORRHOIDAL WITH ALOE (PRAMOXINE HYDROCHLORIDE, ZINC OXIDE) OINTMENT [PERSONAL CARE PRODUCTS, INC.]2Legacy NDC, 1 package rows20200725_a0e3b500-1295-47cd-ab4e-503f51895bbb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1294330pramoxine HCl 1 % / zinc oxide 12.5 % Topical OintmentPSNa0e3b500-1295-47cd-ab4e-503f51895bbb2
1294330pramoxine hydrochloride 0.01 MG/MG / zinc oxide 0.125 MG/MG Topical OintmentSCDa0e3b500-1295-47cd-ab4e-503f51895bbb2
1294330Pramoxine hydrochloride 0.01 MG/MG / ZNO 0.125 MG/MG Topical OintmentSYa0e3b500-1295-47cd-ab4e-503f51895bbb2
1294330pramoxine hydrochloride 1 % / zinc oxide 12.5 % Topical OintmentSYa0e3b500-1295-47cd-ab4e-503f51895bbb2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
29500-2438-12950024380142 g in 1 TUBE (29500-2438-1) 42 g2020-06-010000-00-00NoNoCurrent