STAHIST TP

Product NDC: 58407-010
Requested package NDC: 58407-010-10
11-digit product format: 584070010
Labeler code: 58407
Product ID: 58407-010_a12867fe-22b6-4f6d-a39f-1ad83d01152b
Type: HUMAN OTC DRUG
Nonproprietary name: Phenylephrine HCL and Triprolidine HCL
Dosage form: TABLET
Route: ORAL
Labeler: Magna Pharmaceuticals, Inc.
Application: part341
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2020-05-25
Marketing end: 0000-00-00
Substance: PHENYLEPHRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE
Active strength: 10 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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	58407-010	58407-010-10	I	Inactivated by FDA		2026-10-05

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 · 12 matching rows.

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

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2022-04-09 23:13 UTC · source 2022-04-08	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`

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
30c51294-7ae9-8007-7de6-58222684a0be	Product name	1	20140508
42f3c020-f1b3-89bc-7bdc-e1f10e680485	Product name	1	20140508
e949165d-714d-e548-2b76-0cb5def16f30	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2025-01-30	Stahist TP
2023-10-10	Stahist TP
2023-07-28	Stahist TP
2022-08-17	Stahist TP
2021-07-23	Stahist TP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
58407-010-10	STAHIST TP	100 in 1 BOTTLE	TABLET	100		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
58407-010-10	EA - Each	58407-010	7d8f7389-d6c4-448e-8b96-fb09bdf4e30f	1	2020-07-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58407-010	STAHIST TP (PHENYLEPHRINE HCL AND TRIPROLIDINE HCL) TABLET [MAGNA PHARMACEUTICALS, INC.]	4	Legacy NDC, 1 package rows	20231011_a6b6f593-c35a-d821-e053-2a95a90ab09d.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
04JA59TNSJ	PHENYLEPHRINE HYDROCHLORIDE	61-76-7	PHENYLEPHRINE HYDROCHLORIDE
YAN7R5L890	TRIPROLIDINE HYDROCHLORIDE	6138-79-0	TRIPROLIDINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1099659	phenylephrine HCl 10 MG / triprolidine HCl 2.5 MG Oral Tablet	PSN	a6b6f593-c35a-d821-e053-2a95a90ab09d	4
1099659	phenylephrine hydrochloride 10 MG / triprolidine hydrochloride 2.5 MG Oral Tablet	SCD	a6b6f593-c35a-d821-e053-2a95a90ab09d	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
58407-010-10	58407001010	100 TABLET in 1 BOTTLE (58407-010-10)	100 tablet	2020-05-25	0000-00-00	No	No	Current