FDA.reportPublic FDA data

Avedana Hemorrhoidal Pain Relief

Product NDC
43749-480
11-digit product format
437490480
Labeler code
43749
Product ID
43749-480_d1407fe2-f2d3-a789-e053-2a95a90a14a0
Type
HUMAN OTC DRUG
Nonproprietary name
Mineral Oil, Petrolatum, Phenylephrine HCl
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Unipack, Inc.
Application
part346
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2004-03-01
Marketing end
0000-00-00
Substance
PHENYLEPHRINE HYDROCHLORIDE; MINERAL OIL; PETROLATUM
Active strength
3 mg/g; mg/g; mg/g
NDC exclude flag
No
Listing certified through
2022-12-31
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 productproduct43749-480IInactivated by FDA2026-08-17
excluded packagepackage43749-48043749-480-02IInactivated by FDA2026-08-17

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43749-480-02Avedana Hemorrhoidal Pain Relief57 g in 1 TUBEOINTMENT574
43749-480-02Avedana Hemorrhoidal Pain Relief1 in 1 CARTONOINTMENT14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43749-480-02GM - Gram43749-480507bb8f9-c700-409b-99d8-10e5e5c794e712024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43749-480AVEDANA HEMORRHOIDAL PAIN RELIEF (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [UNIPACK LLC]4Legacy NDC, 2 package rows20241128_b6793080-c727-4553-ae33-d387eb861ca3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1372298mineral oil 14 % / petrolatum 74.9 % / phenylephrine HCl 0.25 % Rectal OintmentPSNb6793080-c727-4553-ae33-d387eb861ca34
1372298mineral oil 0.14 MG/MG / petrolatum 0.749 MG/MG / phenylephrine hydrochloride 0.0025 MG/MG Rectal OintmentSCDb6793080-c727-4553-ae33-d387eb861ca34
1372298mineral oil 14 % / petrolatum 74.9 % / phenylephrine hydrochloride 0.25 % Rectal OintmentSYb6793080-c727-4553-ae33-d387eb861ca34

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43749-480-02437490480021 TUBE in 1 CARTON (43749-480-02) > 57 g in 1 TUBE1 tube2021-01-060000-00-00NoNoCurrent