Proctofoam

Product NDC
68220-143
11-digit product format
682200143
Labeler code
68220
Product ID
68220-143_f2bdbe25-0124-4b39-ab04-77d2250b5835
Type
HUMAN OTC DRUG
Nonproprietary name
pramoxine hydrochloride
Dosage form
AEROSOL, FOAM
Route
RECTAL
Labeler
Alaven Pharmaceutical LLC
Application
part346
Marketing category
OTC MONOGRAPH FINAL
Marketing start
1990-09-30
Marketing end
0000-00-00
Substance
PRAMOXINE HYDROCHLORIDE
Active strength
150 mg/15g
NDC exclude flag
E
Listing certified through
2018-12-31
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 productproduct68220-143DDiscontinued by firm2026-08-17
excluded packagepackage68220-14368220-143-15DDiscontinued by firm2026-08-17

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 · 26 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68220-143-15DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68220-143-15DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductDDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68220-143-15DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductDDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68220-143-15DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductDDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68220-143-15DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductDDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68220-143-15DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductDDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68220-143-15DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductDDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68220-143-15DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductDDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68220-143-15DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductDDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68220-143-15DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductDDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage68220-143-15DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductDDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage68220-143-15DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage68220-143-15EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68220-143-15GM - Gram68220-143a0fbeb58-e5b6-431f-a62a-e67e7b05f4f812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
pramoxine hydrochlorideACTIVE INGREDIENT88AYB867L5PROCTOFOAM (PRAMOXINE HYDROCHLORIDE) AEROSOL, FOAM [ALAVEN PHARMACEUTICAL LLC]1
pramoxine hydrochlorideACTIVE INGREDIENT88AYB867L5PRAMOXINE HYDROCHLORIDE AEROSOL, FOAM [PHYSICIANS TOTAL CARE, INC.]1
pramoxineACTIVE MOIETY068X84E056PROCTOFOAM (PRAMOXINE HYDROCHLORIDE) AEROSOL, FOAM [ALAVEN PHARMACEUTICAL LLC]1
pramoxineACTIVE MOIETY068X84E056PRAMOXINE HYDROCHLORIDE AEROSOL, FOAM [PHYSICIANS TOTAL CARE, INC.]1
cetyl alcoholINACTIVE INGREDIENT936JST6JCNPRAMOXINE HYDROCHLORIDE AEROSOL, FOAM [PHYSICIANS TOTAL CARE, INC.]1
cetyl alcoholINACTIVE INGREDIENT936JST6JCNPROCTOFOAM (PRAMOXINE HYDROCHLORIDE) AEROSOL, FOAM [ALAVEN PHARMACEUTICAL LLC]1
glyceryl monostearateINACTIVE INGREDIENT230OU9XXE4PRAMOXINE HYDROCHLORIDE AEROSOL, FOAM [PHYSICIANS TOTAL CARE, INC.]1
glyceryl monostearateINACTIVE INGREDIENT230OU9XXE4PROCTOFOAM (PRAMOXINE HYDROCHLORIDE) AEROSOL, FOAM [ALAVEN PHARMACEUTICAL LLC]1
isobutaneINACTIVE INGREDIENTBXR49TP611PROCTOFOAM (PRAMOXINE HYDROCHLORIDE) AEROSOL, FOAM [ALAVEN PHARMACEUTICAL LLC]1
isobutaneINACTIVE INGREDIENTBXR49TP611PRAMOXINE HYDROCHLORIDE AEROSOL, FOAM [PHYSICIANS TOTAL CARE, INC.]1
methylparabenINACTIVE INGREDIENTA2I8C7HI9TPROCTOFOAM (PRAMOXINE HYDROCHLORIDE) AEROSOL, FOAM [ALAVEN PHARMACEUTICAL LLC]1
methylparabenINACTIVE INGREDIENTA2I8C7HI9TPRAMOXINE HYDROCHLORIDE AEROSOL, FOAM [PHYSICIANS TOTAL CARE, INC.]1
polyoxyl 40 stearateINACTIVE INGREDIENT13A4J4NH9IPROCTOFOAM (PRAMOXINE HYDROCHLORIDE) AEROSOL, FOAM [ALAVEN PHARMACEUTICAL LLC]1
polyoxyl 40 stearateINACTIVE INGREDIENT13A4J4NH9IPRAMOXINE HYDROCHLORIDE AEROSOL, FOAM [PHYSICIANS TOTAL CARE, INC.]1
propaneINACTIVE INGREDIENTT75W9911L6PRAMOXINE HYDROCHLORIDE AEROSOL, FOAM [PHYSICIANS TOTAL CARE, INC.]1
propaneINACTIVE INGREDIENTT75W9911L6PROCTOFOAM (PRAMOXINE HYDROCHLORIDE) AEROSOL, FOAM [ALAVEN PHARMACEUTICAL LLC]1
propylene glycolINACTIVE INGREDIENT6DC9Q167V3PRAMOXINE HYDROCHLORIDE AEROSOL, FOAM [PHYSICIANS TOTAL CARE, INC.]1
propylene glycolINACTIVE INGREDIENT6DC9Q167V3PROCTOFOAM (PRAMOXINE HYDROCHLORIDE) AEROSOL, FOAM [ALAVEN PHARMACEUTICAL LLC]1
propylparabenINACTIVE INGREDIENTZ8IX2SC1OHPRAMOXINE HYDROCHLORIDE AEROSOL, FOAM [PHYSICIANS TOTAL CARE, INC.]1
propylparabenINACTIVE INGREDIENTZ8IX2SC1OHPROCTOFOAM (PRAMOXINE HYDROCHLORIDE) AEROSOL, FOAM [ALAVEN PHARMACEUTICAL LLC]1
trolamineINACTIVE INGREDIENT9O3K93S3TKPROCTOFOAM (PRAMOXINE HYDROCHLORIDE) AEROSOL, FOAM [ALAVEN PHARMACEUTICAL LLC]1
trolamineINACTIVE INGREDIENT9O3K93S3TKPRAMOXINE HYDROCHLORIDE AEROSOL, FOAM [PHYSICIANS TOTAL CARE, INC.]1
waterINACTIVE INGREDIENT059QF0KO0RPRAMOXINE HYDROCHLORIDE AEROSOL, FOAM [PHYSICIANS TOTAL CARE, INC.]1
waterINACTIVE INGREDIENT059QF0KO0RPROCTOFOAM (PRAMOXINE HYDROCHLORIDE) AEROSOL, FOAM [ALAVEN PHARMACEUTICAL LLC]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828365pramoxine HCl 1 % Rectal FoamPSN0494f952-de65-49d8-a8a6-5ee5abd536191
828365pramoxine hydrochloride 10 MG/ML Rectal FoamSCD0494f952-de65-49d8-a8a6-5ee5abd536191
828365pramoxine hydrochloride 1 % Rectal FoamSY0494f952-de65-49d8-a8a6-5ee5abd536191