Avedana Hemorrhoidal

Product NDC: 43749-430
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

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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	43749-430		I	Inactivated by FDA	2026-08-17
excluded product	product	43749-430		I	Inactivated by FDA	2026-08-17
excluded package	package	43749-430	43749-430-12	I	Inactivated by FDA	2026-08-17
excluded package	package	43749-430	43749-430-24	I	Inactivated by FDA	2026-08-17

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 · 28 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43749-430-24	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43749-430-24	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43749-430-24	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43749-430-24	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43749-430-24	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43749-430-24	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	43749-430-24	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	43749-430-24	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	43749-430-24	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	43749-430-25	E	Excluded after deficient or non-compliant submission was not corrected	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	43749-430-13	E	Excluded after deficient or non-compliant submission was not corrected	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	43749-430-25	E	Excluded after deficient or non-compliant submission was not corrected	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	43749-430-13	E	Excluded after deficient or non-compliant submission was not corrected	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	43749-430-25	E	Excluded after deficient or non-compliant submission was not corrected	`bd6a592717d7…`	`303034d00443…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e4e263da-1c53-440f-bb80-b7a575843b5a	Product name	1	20260313
d2168cac-a261-415a-9c78-3522859fa720	Product name	3	20251124
05a8cdd1-eeb8-409e-b938-0778225eca7d	Product name	4	20250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9	Product name	8	20250220
f489e8f3-5c9e-4818-b539-a73587edcfc7	Product name	2	20240229
0f7ae452-206d-4fc4-868d-56fc47074084	Product name	1	20231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3df	Product name	2	20190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814	Product name	3	20150910
42f3c020-f1b3-89bc-7bdc-e1f10e680485	Product name	1	20140508
e949165d-714d-e548-2b76-0cb5def16f30	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
43749-430-24	2025-01-30	C162847	48780-1	2cef2736-8ba6-d83d-e063-dadaa90ab31f	AVEDANA ® 24 ct Hemorrhoidal Rectal Suppository

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
43749-430-12	Avedana Hemorrhoidal	2 in 1 CARTON	SUPPOSITORY	2	9
43749-430-13	Avedana Hemorrhoidal	6 in 1 BLISTER PACK	SUPPOSITORY	6	9
43749-430-24	Avedana Hemorrhoidal	4 in 1 CARTON	SUPPOSITORY	4	5
43749-430-25	Avedana Hemorrhoidal	6 in 1 BLISTER PACK	SUPPOSITORY	6	5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43749-430-12	EA - Each	43749-430	ed6dcb1a-7cac-4cff-b720-b5217e9cd357	1	2024-04-05
43749-430-24	EA - Each	43749-430	85404f34-8931-474c-aebf-3e0f90852652	1	2024-04-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
COCOA BUTTER	ACTIVE INGREDIENT	512OYT1CRR	AVEDANA HEMORRHOIDAL (HEMORRHOIDAL RECTAL SUPPOSITORIES) SUPPOSITORY [UNIPACK, INC.]	1
PHENYLEPHRINE HYDROCHLORIDE	ACTIVE INGREDIENT	04JA59TNSJ	AVEDANA HEMORRHOIDAL (HEMORRHOIDAL RECTAL SUPPOSITORIES) SUPPOSITORY [UNIPACK, INC.]	1
COCOA BUTTER	ACTIVE MOIETY	512OYT1CRR	AVEDANA HEMORRHOIDAL (HEMORRHOIDAL RECTAL SUPPOSITORIES) SUPPOSITORY [UNIPACK, INC.]	1
PHENYLEPHRINE	ACTIVE MOIETY	1WS297W6MV	AVEDANA HEMORRHOIDAL (HEMORRHOIDAL RECTAL SUPPOSITORIES) SUPPOSITORY [UNIPACK, INC.]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	AVEDANA HEMORRHOIDAL (HEMORRHOIDAL RECTAL SUPPOSITORIES) SUPPOSITORY [UNIPACK, INC.]	1
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)	INACTIVE INGREDIENT	461P5CJN6T	AVEDANA HEMORRHOIDAL (HEMORRHOIDAL RECTAL SUPPOSITORIES) SUPPOSITORY [UNIPACK, INC.]	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	AVEDANA HEMORRHOIDAL (HEMORRHOIDAL RECTAL SUPPOSITORIES) SUPPOSITORY [UNIPACK, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43749-430	AVEDANA HEMORRHOIDAL (HEMORRHOIDAL RECTAL SUPPOSITORIES) SUPPOSITORY [UNIPACK LLC]	9	Legacy NDC, 2 package rows	20241128_4defc910-1f4b-4a87-8bdd-9d71d8cadd93.zip
43749-430	AVEDANA HEMORRHOIDAL (HEMORRHOIDAL RECTAL SUPPOSITORIES) SUPPOSITORY [UNIPACK LLC]	5	Legacy NDC, 2 package rows	20230120_9009c9f6-81aa-4b32-8161-1fe8e08a6374.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
512OYT1CRR	COCOA BUTTER	8002-31-1	COCOA BUTTER
04JA59TNSJ	PHENYLEPHRINE HYDROCHLORIDE	61-76-7	PHENYLEPHRINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1438497	cocoa butter 88.4 % / phenylephrine HCl 0.25 % Rectal Suppository	PSN	4defc910-1f4b-4a87-8bdd-9d71d8cadd93	9
1438497	cocoa butter 0.884 MG/MG / phenylephrine hydrochloride 0.0025 MG/MG Rectal Suppository	SCD	4defc910-1f4b-4a87-8bdd-9d71d8cadd93	9
1438497	cocoa butter 88.4 % / phenylephrine HCl 0.25 % Rectal Suppository	SY	4defc910-1f4b-4a87-8bdd-9d71d8cadd93	9
1438497	cocoa butter 88.4 % / phenylephrine HCl 0.25 % Rectal Suppository	PSN	9009c9f6-81aa-4b32-8161-1fe8e08a6374	5
1438497	cocoa butter 0.884 MG/MG / phenylephrine hydrochloride 0.0025 MG/MG Rectal Suppository	SCD	9009c9f6-81aa-4b32-8161-1fe8e08a6374	5
1438497	cocoa butter 88.4 % / phenylephrine HCl 0.25 % Rectal Suppository	SY	9009c9f6-81aa-4b32-8161-1fe8e08a6374	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
43749-430-12	43749043012	2 BLISTER PACK in 1 CARTON (43749-430-12) > 6 SUPPOSITORY in 1 BLISTER PACK (43749-430-13)	2 blister pack	2017-09-17	0000-00-00	No	No	Current
43749-430-13	43749043013	2 BLISTER PACK in 1 CARTON (43749-430-13) > 12 g in 1 BLISTER PACK (43749-430-12)	2 blister pack	2017-09-17	0000-00-00	No	No	Current
43749-430-24	43749043024	4 BLISTER PACK in 1 CARTON (43749-430-24) > 6 SUPPOSITORY in 1 BLISTER PACK (43749-430-25)	4 blister pack	2020-10-26	0000-00-00	No	No	Current
43749-430-25	43749043025	4 BLISTER PACK in 1 CARTON (43749-430-25) > 12 g in 1 BLISTER PACK (43749-430-24)	4 blister pack	2020-10-26	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Avedana ® 12 ct Hemorrhoidal Rectal Suppository	Unipack LLC	2024-11-26	HUMAN OTC DRUG LABEL	9
AVEDANA ® 24 ct Hemorrhoidal Rectal Suppository	Unipack LLC	2023-01-16	HUMAN OTC DRUG LABEL	5