FDA.reportPublic FDA data

Avedana Hemorrhoidal

Product NDC
43749-430
Requested package NDC
43749-430-25
11-digit product format
437490430
Labeler code
43749
Product ID
43749-430_d5fbcd1b-0918-8db2-e053-2a95a90a47fb
Type
HUMAN OTC DRUG
Nonproprietary name
Hemorrhoidal Rectal Suppositories
Dosage form
SUPPOSITORY
Route
RECTAL
Labeler
Unipack, Inc.
Application
part346
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2020-10-26
Marketing end
0000-00-00
Substance
COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE
Active strength
2211 mg/1; mg/1
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

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 · 3 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage43749-43043749-430-25EExcluded after deficient or non-compliant submission was not correctedexcluded / ndc_excluded.zipfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage43749-43043749-430-25EExcluded after deficient or non-compliant submission was not correctedexcluded / ndc_excluded.zip86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage43749-43043749-430-25EExcluded after deficient or non-compliant submission was not correctedexcluded / ndc_excluded.zipbd6a592717d7…303034d00443…

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
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
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
43749-430-242025-01-30C16284748780-12cef2736-8ba6-d83d-e063-dadaa90ab31fAVEDANA ® 24 ct Hemorrhoidal Rectal Suppository

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43749-430-12Avedana Hemorrhoidal2 in 1 CARTONSUPPOSITORY29
43749-430-13Avedana Hemorrhoidal6 in 1 BLISTER PACKSUPPOSITORY69
43749-430-24Avedana Hemorrhoidal4 in 1 CARTONSUPPOSITORY45
43749-430-25Avedana Hemorrhoidal6 in 1 BLISTER PACKSUPPOSITORY65

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43749-430-12EA - Each43749-430ed6dcb1a-7cac-4cff-b720-b5217e9cd35712024-04-05
43749-430-24EA - Each43749-43085404f34-8931-474c-aebf-3e0f9085265212024-04-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
COCOA BUTTERACTIVE INGREDIENT512OYT1CRRAVEDANA HEMORRHOIDAL (HEMORRHOIDAL RECTAL SUPPOSITORIES) SUPPOSITORY [UNIPACK, INC.]1
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJAVEDANA HEMORRHOIDAL (HEMORRHOIDAL RECTAL SUPPOSITORIES) SUPPOSITORY [UNIPACK, INC.]1
COCOA BUTTERACTIVE MOIETY512OYT1CRRAVEDANA HEMORRHOIDAL (HEMORRHOIDAL RECTAL SUPPOSITORIES) SUPPOSITORY [UNIPACK, INC.]1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVAVEDANA HEMORRHOIDAL (HEMORRHOIDAL RECTAL SUPPOSITORIES) SUPPOSITORY [UNIPACK, INC.]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TAVEDANA HEMORRHOIDAL (HEMORRHOIDAL RECTAL SUPPOSITORIES) SUPPOSITORY [UNIPACK, INC.]1
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)INACTIVE INGREDIENT461P5CJN6TAVEDANA HEMORRHOIDAL (HEMORRHOIDAL RECTAL SUPPOSITORIES) SUPPOSITORY [UNIPACK, INC.]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHAVEDANA HEMORRHOIDAL (HEMORRHOIDAL RECTAL SUPPOSITORIES) SUPPOSITORY [UNIPACK, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43749-430AVEDANA HEMORRHOIDAL (HEMORRHOIDAL RECTAL SUPPOSITORIES) SUPPOSITORY [UNIPACK LLC]9Legacy NDC, 2 package rows20241128_4defc910-1f4b-4a87-8bdd-9d71d8cadd93.zip
43749-430AVEDANA HEMORRHOIDAL (HEMORRHOIDAL RECTAL SUPPOSITORIES) SUPPOSITORY [UNIPACK LLC]5Legacy NDC, 2 package rows20230120_9009c9f6-81aa-4b32-8161-1fe8e08a6374.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1438497cocoa butter 88.4 % / phenylephrine HCl 0.25 % Rectal SuppositoryPSN4defc910-1f4b-4a87-8bdd-9d71d8cadd939
1438497cocoa butter 0.884 MG/MG / phenylephrine hydrochloride 0.0025 MG/MG Rectal SuppositorySCD4defc910-1f4b-4a87-8bdd-9d71d8cadd939
1438497cocoa butter 88.4 % / phenylephrine HCl 0.25 % Rectal SuppositorySY4defc910-1f4b-4a87-8bdd-9d71d8cadd939
1438497cocoa butter 88.4 % / phenylephrine HCl 0.25 % Rectal SuppositoryPSN9009c9f6-81aa-4b32-8161-1fe8e08a63745
1438497cocoa butter 0.884 MG/MG / phenylephrine hydrochloride 0.0025 MG/MG Rectal SuppositorySCD9009c9f6-81aa-4b32-8161-1fe8e08a63745
1438497cocoa butter 88.4 % / phenylephrine HCl 0.25 % Rectal SuppositorySY9009c9f6-81aa-4b32-8161-1fe8e08a63745

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43749-430-25437490430254 BLISTER PACK in 1 CARTON (43749-430-25) > 12 g in 1 BLISTER PACK (43749-430-24) 4 blister pack2020-10-260000-00-00NoNoCurrent