Childrens Uniphed

Product NDC: 53807-422
11-digit product format: 538070422
Labeler code: 53807
Product ID: 53807-422_bcdd7c98-facc-4c2b-b5b9-4ef4eb0809fd
Type: HUMAN OTC DRUG
Nonproprietary name: Pseudoephedrine hydrochloride
Dosage form: LIQUID
Route: ORAL
Labeler: Rij Pharmaceutical Corporation
Application: part341
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 1999-03-16
Marketing end: 0000-00-00
Substance: PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength: 15 mg/5mL
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	53807-422		I	Inactivated by FDA		2026-11-13
excluded package	package	53807-422	53807-422-04	I	Inactivated by FDA		2026-11-13

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 · 42 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	53807-422-04	`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	53807-422-04	`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	53807-422-04	`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	53807-422-04	`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	53807-422-04	`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	53807-422-04	`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	53807-422-04	`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	53807-422-04	`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	53807-422-04	`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	53807-422-04	`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	53807-422-04	`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	53807-422-04	`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	53807-422-04	`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	53807-422-04	`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	53807-422-04	`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	53807-422-04	`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	53807-422-04	`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	53807-422-04	`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	53807-422-04	`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	53807-422-04	`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	53807-422-04	`9bebd1f3094a…`	`5416666fcb17…`

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
53807-422-04	2020-01-31	C162847	48780-1	9d75b9d0-7d4a-f424-e053-dadaa90a57ce	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53807-422-04	Childrens Uniphed Nasal Decongestant	118 mL in 1 BOTTLE	LIQUID	118		2

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Pseudoephedrine hydrochloride	ACTIVE INGREDIENT	6V9V2RYJ8N	CHILDRENS UNIPHED NASAL DECONGESTANT (PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [RIJ PHARMACEUTICAL CORPORATION]	1
Pseudoephedrine	ACTIVE MOIETY	7CUC9DDI9F	CHILDRENS UNIPHED NASAL DECONGESTANT (PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [RIJ PHARMACEUTICAL CORPORATION]	1
anhydrous citric acid	INACTIVE INGREDIENT	XF417D3PSL	CHILDRENS UNIPHED NASAL DECONGESTANT (PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [RIJ PHARMACEUTICAL CORPORATION]	1
edetate disodium	INACTIVE INGREDIENT	7FLD91C86K	CHILDRENS UNIPHED NASAL DECONGESTANT (PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [RIJ PHARMACEUTICAL CORPORATION]	1
FD&C blue no. 1	INACTIVE INGREDIENT	H3R47K3TBD	CHILDRENS UNIPHED NASAL DECONGESTANT (PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [RIJ PHARMACEUTICAL CORPORATION]	1
FD&C red no. 40	INACTIVE INGREDIENT	WZB9127XOA	CHILDRENS UNIPHED NASAL DECONGESTANT (PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [RIJ PHARMACEUTICAL CORPORATION]	1
glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	CHILDRENS UNIPHED NASAL DECONGESTANT (PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [RIJ PHARMACEUTICAL CORPORATION]	1
poloxamer 407	INACTIVE INGREDIENT	TUF2IVW3M2	CHILDRENS UNIPHED NASAL DECONGESTANT (PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [RIJ PHARMACEUTICAL CORPORATION]	1
polyethylene glycols	INACTIVE INGREDIENT	3WJQ0SDW1A	CHILDRENS UNIPHED NASAL DECONGESTANT (PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [RIJ PHARMACEUTICAL CORPORATION]	1
povidone K90	INACTIVE INGREDIENT	RDH86HJV5Z	CHILDRENS UNIPHED NASAL DECONGESTANT (PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [RIJ PHARMACEUTICAL CORPORATION]	1
saccharin sodium	INACTIVE INGREDIENT	SB8ZUX40TY	CHILDRENS UNIPHED NASAL DECONGESTANT (PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [RIJ PHARMACEUTICAL CORPORATION]	1
sodium benzoate	INACTIVE INGREDIENT	OJ245FE5EU	CHILDRENS UNIPHED NASAL DECONGESTANT (PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [RIJ PHARMACEUTICAL CORPORATION]	1
sodium citrate	INACTIVE INGREDIENT	1Q73Q2JULR	CHILDRENS UNIPHED NASAL DECONGESTANT (PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [RIJ PHARMACEUTICAL CORPORATION]	1
sorbitol	INACTIVE INGREDIENT	506T60A25R	CHILDRENS UNIPHED NASAL DECONGESTANT (PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [RIJ PHARMACEUTICAL CORPORATION]	1
water	INACTIVE INGREDIENT	059QF0KO0R	CHILDRENS UNIPHED NASAL DECONGESTANT (PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [RIJ PHARMACEUTICAL CORPORATION]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53807-422	CHILDRENS UNIPHED NASAL DECONGESTANT (PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [RIJ PHARMACEUTICAL CORPORATION]	2	Legacy NDC, 1 package rows	20180502_c9b8e416-dd97-483a-b155-15f611037681.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
1049143	pseudoephedrine HCl 15 MG in 5 mL Oral Solution	PSN	c9b8e416-dd97-483a-b155-15f611037681	2
1049143	pseudoephedrine hydrochloride 3 MG/ML Oral Solution	SCD	c9b8e416-dd97-483a-b155-15f611037681	2
1049143	pseudoephedrine hydrochloride 15 MG per 5 ML Oral Solution	SY	c9b8e416-dd97-483a-b155-15f611037681	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
53807-422-04	53807042204	118 mL in 1 BOTTLE	118 ml	Historical