PSEUDO-TIME

Product NDC: 49483-016
11-digit product format: 494830016
Labeler code: 49483
Product ID: 49483-016_ad109144-ae93-4679-9b66-927a1a89cea2
Type: HUMAN OTC DRUG
Nonproprietary name: PSEUDOEPHEDRINE HCL
Dosage form: TABLET, COATED
Route: ORAL
Labeler: TIME CAP LABORATORIES, INC.
Application: part341
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2012-05-01
Marketing end: 0000-00-00
Substance: PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength: 30 mg/1
NDC exclude flag: No
Listing certified through: 2019-12-31
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	49483-016		I	Inactivated by FDA	2026-10-05
excluded package	package	49483-016	49483-016-24	I	Inactivated by FDA	2026-10-05
excluded package	package	49483-016	49483-016-48	I	Inactivated by FDA	2026-10-05
excluded package	package	49483-016	49483-016-96	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 2 · 84 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	49483-016-96	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	49483-016-24	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	49483-016-48	`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	49483-016-96	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	49483-016-24	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	49483-016-48	`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	49483-016-96	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	49483-016-24	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	49483-016-48	`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	49483-016-96	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	49483-016-24	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	49483-016-48	`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	49483-016-96	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	49483-016-24	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	49483-016-48	`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	49483-016-96	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	49483-016-24	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	49483-016-48	`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	49483-016-96	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	49483-016-24	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	49483-016-48	`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	49483-016-96	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	49483-016-24	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	49483-016-48	`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	49483-016-96	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	49483-016-24	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	49483-016-48	`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	49483-016-96	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	49483-016-24	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	49483-016-48	`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	49483-016-96	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	49483-016-24	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	49483-016-48	`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	49483-016-96	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	49483-016-24	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	49483-016-48	`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	49483-016-96	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	49483-016-24	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	49483-016-48	`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	49483-016-96	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	49483-016-24	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	49483-016-48	`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	49483-016-96	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	49483-016-24	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	49483-016-48	`1332a3947898…`	`d4bfe170f9cd…`

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
ba088a92-ab5e-b2d4-e908-f5ea691b7587	Product name	7	20210201
0fdb98e2-b951-a1ce-5715-2b187ba500ef	Product name	4	20170718
e974e22d-8688-7d92-1e87-40c1079e170c	Product name	3	20151125
e8718272-64cb-4436-969b-176c3067c8f4	Product name	1	20150609
30c51294-7ae9-8007-7de6-58222684a0be	Product name	1	20140508
4f26f669-fc6c-40ef-9e26-1c7b2390ee66	Product name	1	20140508
70a83adc-6047-bbea-5a08-dfd304aa47d2	Product name	1	20140508
858ce051-9941-aafc-8c7c-44a8e0227463	Product name	1	20140508
b893258d-0942-3d8a-3411-056ea0788ff5	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
49483-016-24	2020-01-31	C162847	48780-1	9d75b9d0-038e-f424-e053-dadaa90a57ce	d8dace20-752e-4686-8026-c8fc97591fa8
49483-016-48	2020-01-31	C162847	48780-1	9d75b9d0-038e-f424-e053-dadaa90a57ce	d8dace20-752e-4686-8026-c8fc97591fa8
49483-016-96	2020-01-31	C162847	48780-1	9d75b9d0-038e-f424-e053-dadaa90a57ce	d8dace20-752e-4686-8026-c8fc97591fa8

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
49483-016-24	PSEUDO-TIME	24 in 1 BLISTER PACK	TABLET, COATED	24	2
49483-016-48	PSEUDO-TIME	48 in 1 BLISTER PACK	TABLET, COATED	48	2
49483-016-96	PSEUDO-TIME	96 in 1 BLISTER PACK	TABLET, COATED	96	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
49483-016-24	EA - Each	49483-016	b7510b74-4714-49b4-9680-8fad1f3a5c75	1	2017-04-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PSEUDOEPHEDRINE HYDROCHLORIDE	ACTIVE INGREDIENT	6V9V2RYJ8N	PSEUDO-TIME (PSEUDOEPHEDRINE HCL) TABLET, COATED [TIME CAP LABORATORIES, INC.]	2
PSEUDOEPHEDRINE	ACTIVE MOIETY	7CUC9DDI9F	PSEUDO-TIME (PSEUDOEPHEDRINE HCL) TABLET, COATED [TIME CAP LABORATORIES, INC.]	2
ACACIA	INACTIVE INGREDIENT	5C5403N26O	PSEUDO-TIME (PSEUDOEPHEDRINE HCL) TABLET, COATED [TIME CAP LABORATORIES, INC.]	2
CALCIUM SULFATE ANHYDROUS	INACTIVE INGREDIENT	E934B3V59H	PSEUDO-TIME (PSEUDOEPHEDRINE HCL) TABLET, COATED [TIME CAP LABORATORIES, INC.]	2
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	PSEUDO-TIME (PSEUDOEPHEDRINE HCL) TABLET, COATED [TIME CAP LABORATORIES, INC.]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	PSEUDO-TIME (PSEUDOEPHEDRINE HCL) TABLET, COATED [TIME CAP LABORATORIES, INC.]	2
D&C RED NO. 27	INACTIVE INGREDIENT	2LRS185U6K	PSEUDO-TIME (PSEUDOEPHEDRINE HCL) TABLET, COATED [TIME CAP LABORATORIES, INC.]	2
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	PSEUDO-TIME (PSEUDOEPHEDRINE HCL) TABLET, COATED [TIME CAP LABORATORIES, INC.]	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	PSEUDO-TIME (PSEUDOEPHEDRINE HCL) TABLET, COATED [TIME CAP LABORATORIES, INC.]	2
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	PSEUDO-TIME (PSEUDOEPHEDRINE HCL) TABLET, COATED [TIME CAP LABORATORIES, INC.]	2
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	PSEUDO-TIME (PSEUDOEPHEDRINE HCL) TABLET, COATED [TIME CAP LABORATORIES, INC.]	2
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	PSEUDO-TIME (PSEUDOEPHEDRINE HCL) TABLET, COATED [TIME CAP LABORATORIES, INC.]	2
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	PSEUDO-TIME (PSEUDOEPHEDRINE HCL) TABLET, COATED [TIME CAP LABORATORIES, INC.]	2
KAOLIN	INACTIVE INGREDIENT	24H4NWX5CO	PSEUDO-TIME (PSEUDOEPHEDRINE HCL) TABLET, COATED [TIME CAP LABORATORIES, INC.]	2
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	PSEUDO-TIME (PSEUDOEPHEDRINE HCL) TABLET, COATED [TIME CAP LABORATORIES, INC.]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	PSEUDO-TIME (PSEUDOEPHEDRINE HCL) TABLET, COATED [TIME CAP LABORATORIES, INC.]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	PSEUDO-TIME (PSEUDOEPHEDRINE HCL) TABLET, COATED [TIME CAP LABORATORIES, INC.]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	PSEUDO-TIME (PSEUDOEPHEDRINE HCL) TABLET, COATED [TIME CAP LABORATORIES, INC.]	2
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	PSEUDO-TIME (PSEUDOEPHEDRINE HCL) TABLET, COATED [TIME CAP LABORATORIES, INC.]	2
SUCROSE	INACTIVE INGREDIENT	C151H8M554	PSEUDO-TIME (PSEUDOEPHEDRINE HCL) TABLET, COATED [TIME CAP LABORATORIES, INC.]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	PSEUDO-TIME (PSEUDOEPHEDRINE HCL) TABLET, COATED [TIME CAP LABORATORIES, INC.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	PSEUDO-TIME (PSEUDOEPHEDRINE HCL) TABLET, COATED [TIME CAP LABORATORIES, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49483-016	PSEUDO-TIME (PSEUDOEPHEDRINE HCL) TABLET, COATED [TIME CAP LABORATORIES, INC.]	2	Legacy NDC, 3 package rows	20120813_d8dace20-752e-4686-8026-c8fc97591fa8.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
6V9V2RYJ8N	PSEUDOEPHEDRINE HYDROCHLORIDE	345-78-8	PSEUDOEPHEDRINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1049160	pseudoephedrine HCl 30 MG Oral Tablet	PSN	d8dace20-752e-4686-8026-c8fc97591fa8	2
1049160	pseudoephedrine hydrochloride 30 MG Oral Tablet	SCD	d8dace20-752e-4686-8026-c8fc97591fa8	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
49483-016-24	49483001624	24 in 1 BLISTER PACK	Historical
49483-016-48	49483001648	48 in 1 BLISTER PACK	Historical
49483-016-96	49483001696	96 in 1 BLISTER PACK	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PSEUDO-TIME - TIME CAP LABORATORIES, INC.	TIME CAP LABORATORIES, INC.	2012-07-23	HUMAN OTC DRUG LABEL	2