phenylephrine hydrochloride

Product NDC: 50730-4812
11-digit product format: 507304812
Labeler code: 50730
Product ID: 50730-4812_1065863d-fc11-4ca8-86f2-76ba8eba05c5
Type: HUMAN OTC DRUG
Nonproprietary name: phenylephrine hydrochloride
Dosage form: SUPPOSITORY
Route: RECTAL
Labeler: H and P Industries, Inc. dba Triad Group
Application: part346
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2009-03-01
Marketing end: 0000-00-00
Substance: COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE; SHARK LIVER OIL
Active strength: 2077 mg/1; mg/1; mg/1
NDC exclude flag: E
Listing certified through: 2017-12-31
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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	50730-4812		I	Inactivated by FDA		2026-09-14
excluded package	package	50730-4812	50730-4812-0	I	Inactivated by FDA		2026-09-14

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 · 44 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50730-4812-0	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50730-4812-0	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50730-4812-0	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50730-4812-0	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50730-4812-0	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50730-4812-0	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50730-4812-0	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50730-4812-0	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	50730-4812-0	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	50730-4812-0	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	50730-4812-0	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	50730-4812-0	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	50730-4812-0	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	50730-4812-0	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	50730-4812-0	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	50730-4812-0	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	50730-4812-0	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	50730-4812-0	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	50730-4812-0	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	50730-4812-0	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	50730-4812-0	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	50730-4812-0	`110d247fa046…`	`a55b01930146…`

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 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
50730-4812-0	2019-10-21	C162847	48780-1	956f9ecf-ca08-621f-e053-dbdaa90a74ad	DRUG FACTS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50730-4812-0	phenylephrine hydrochloride	12 in 1 BOX	SUPPOSITORY	12		1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
cocoa butter	ACTIVE INGREDIENT	512OYT1CRR	PHENYLEPHRINE HYDROCHLORIDE SUPPOSITORY [H AND P INDUSTRIES, INC. DBA TRIAD GROUP]	1
phenylephrine hydrochloride	ACTIVE INGREDIENT	04JA59TNSJ	PHENYLEPHRINE HYDROCHLORIDE SUPPOSITORY [H AND P INDUSTRIES, INC. DBA TRIAD GROUP]	1
shark liver oil	ACTIVE INGREDIENT	4B24275HEU	PHENYLEPHRINE HYDROCHLORIDE SUPPOSITORY [H AND P INDUSTRIES, INC. DBA TRIAD GROUP]	1
cocoa butter	ACTIVE MOIETY	512OYT1CRR	PHENYLEPHRINE HYDROCHLORIDE SUPPOSITORY [H AND P INDUSTRIES, INC. DBA TRIAD GROUP]	1
phenylephrine	ACTIVE MOIETY	1WS297W6MV	PHENYLEPHRINE HYDROCHLORIDE SUPPOSITORY [H AND P INDUSTRIES, INC. DBA TRIAD GROUP]	1
shark liver oil	ACTIVE MOIETY	4B24275HEU	PHENYLEPHRINE HYDROCHLORIDE SUPPOSITORY [H AND P INDUSTRIES, INC. DBA TRIAD GROUP]	1
methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	PHENYLEPHRINE HYDROCHLORIDE SUPPOSITORY [H AND P INDUSTRIES, INC. DBA TRIAD GROUP]	1
propylparaben	INACTIVE INGREDIENT	Z8IX2SC1OH	PHENYLEPHRINE HYDROCHLORIDE SUPPOSITORY [H AND P INDUSTRIES, INC. DBA TRIAD GROUP]	1
starch, corn	INACTIVE INGREDIENT	O8232NY3SJ	PHENYLEPHRINE HYDROCHLORIDE SUPPOSITORY [H AND P INDUSTRIES, INC. DBA TRIAD GROUP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50730-4812	PHENYLEPHRINE HYDROCHLORIDE SUPPOSITORY [H AND P INDUSTRIES, INC. DBA TRIAD GROUP]	1	Legacy NDC, 1 package rows	20091209_054fc819-6fbb-483e-89fb-71b58d094c9b.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
4B24275HEU	SHARK LIVER OIL	68990-63-6	SHARK LIVER OIL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
259093	cocoa butter 85.5 % / phenylephrine HCl 0.25 % / shark liver oil 3 % Rectal Suppository	PSN	054fc819-6fbb-483e-89fb-71b58d094c9b	1
259093	cocoa butter 0.855 MG/MG / phenylephrine 0.0025 MG/MG / shark liver oil 0.03 MG/MG Rectal Suppository	SCD	054fc819-6fbb-483e-89fb-71b58d094c9b	1
259093	cocoa butter 85.5 % / phenylephrine 0.25 % / shark liver oil preparation 3 % Rectal Suppository	SY	054fc819-6fbb-483e-89fb-71b58d094c9b	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
50730-4812-0	50730481200	12 in 1 BOX	Historical