Rugby

Product NDC
0536-1850
11-digit product format
005361850
Labeler code
0536
Product ID
0536-1850_936493a4-840d-59cc-e053-2a95a90ab836
Type
HUMAN OTC DRUG
Nonproprietary name
Pseudoephedrine Hydrochloride
Dosage form
LIQUID
Route
ORAL
Labeler
Rugby Laboratories, Inc.
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
1999-07-26
Marketing end
2020-09-30
Substance
PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength
30 mg/5mL
NDC exclude flag
No
Listing certified through
0000-00-00
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0536-1850DDiscontinued by firm2026-08-17
excluded packagepackage0536-18500536-1850-85DDiscontinued by firm2026-08-17
excluded packagepackage0536-18500536-1850-97DDiscontinued by firm2026-08-17

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 · 36 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0536-1850-85d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0536-1850-97d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0536-1850-85f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0536-1850-97f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0536-1850-852ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0536-1850-972ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0536-1850-85a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0536-1850-97a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0536-1850-85cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0536-1850-97cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0536-1850-85cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0536-1850-97cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0536-1850-85302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0536-1850-97302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0536-1850-85ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0536-1850-97ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0536-1850-850efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0536-1850-970efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0536-1850-85ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0536-1850-97ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0536-1850-85367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0536-1850-97367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0536-1850-85557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0536-1850-97557ba5c1ecfa…9c80585c8c6e…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
e974e22d-8688-7d92-1e87-40c1079e170cProduct name320151125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
30c51294-7ae9-8007-7de6-58222684a0beProduct name120140508
4f26f669-fc6c-40ef-9e26-1c7b2390ee66Product name120140508
70a83adc-6047-bbea-5a08-dfd304aa47d2Product name120140508
858ce051-9941-aafc-8c7c-44a8e0227463Product name120140508
b893258d-0942-3d8a-3411-056ea0788ff5Product name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-1850-85ML - Milliliter0536-1850233e0ba0-7061-44a9-abf5-c56adbecab3d12012-07-24
0536-1850-97ML - Milliliter0536-1850ad2ff551-290e-4f1f-849b-57e8962cf53412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PSEUDOEPHEDRINE HYDROCHLORIDEACTIVE INGREDIENT6V9V2RYJ8NRUGBY NASAL DECONGESTANT (PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [BRYANT RANCH PREPACK]1000
PSEUDOEPHEDRINEACTIVE MOIETY7CUC9DDI9FRUGBY NASAL DECONGESTANT (PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [BRYANT RANCH PREPACK]1000
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPRUGBY NASAL DECONGESTANT (PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [BRYANT RANCH PREPACK]1000
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOARUGBY NASAL DECONGESTANT (PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [BRYANT RANCH PREPACK]1000
GLYCERININACTIVE INGREDIENTPDC6A3C0OXRUGBY NASAL DECONGESTANT (PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [BRYANT RANCH PREPACK]1000
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TRUGBY NASAL DECONGESTANT (PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [BRYANT RANCH PREPACK]1000
RASPBERRYINACTIVE INGREDIENT4N14V5R27WRUGBY NASAL DECONGESTANT (PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [BRYANT RANCH PREPACK]1000
SACCHARIN SODIUM DIHYDRATEINACTIVE INGREDIENTSB8ZUX40TYRUGBY NASAL DECONGESTANT (PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [BRYANT RANCH PREPACK]1000
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EURUGBY NASAL DECONGESTANT (PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [BRYANT RANCH PREPACK]1000
SORBITOLINACTIVE INGREDIENT506T60A25RRUGBY NASAL DECONGESTANT (PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [BRYANT RANCH PREPACK]1000
WATERINACTIVE INGREDIENT059QF0KO0RRUGBY NASAL DECONGESTANT (PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [BRYANT RANCH PREPACK]1000
Pseudoephedrine HydrochlorideACTIVE INGREDIENT6V9V2RYJ8NRUGBY (PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [RUGBY LABORATORIES, INC.]1
Pseudoephedrine HydrochlorideACTIVE INGREDIENT6V9V2RYJ8NRUGBY NASAL DECONGESTANT NASAL DECONGESTANT (PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [DISPENSING SOLUTIONS, INC.]1
PseudoephedrineACTIVE MOIETY7CUC9DDI9FRUGBY (PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [RUGBY LABORATORIES, INC.]1
PseudoephedrineACTIVE MOIETY7CUC9DDI9FRUGBY NASAL DECONGESTANT NASAL DECONGESTANT (PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [DISPENSING SOLUTIONS, INC.]1
Citric Acid MonohydrateINACTIVE INGREDIENT2968PHW8QPRUGBY NASAL DECONGESTANT NASAL DECONGESTANT (PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [DISPENSING SOLUTIONS, INC.]1
Citric Acid MonohydrateINACTIVE INGREDIENT2968PHW8QPRUGBY (PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [RUGBY LABORATORIES, INC.]1
FD&C Red no. 40INACTIVE INGREDIENTWZB9127XOARUGBY NASAL DECONGESTANT NASAL DECONGESTANT (PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [DISPENSING SOLUTIONS, INC.]1
FD&C Red no. 40INACTIVE INGREDIENTWZB9127XOARUGBY (PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [RUGBY LABORATORIES, INC.]1
GlycerinINACTIVE INGREDIENTPDC6A3C0OXRUGBY NASAL DECONGESTANT NASAL DECONGESTANT (PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [DISPENSING SOLUTIONS, INC.]1
GlycerinINACTIVE INGREDIENTPDC6A3C0OXRUGBY (PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [RUGBY LABORATORIES, INC.]1
MethylparabenINACTIVE INGREDIENTA2I8C7HI9TRUGBY NASAL DECONGESTANT NASAL DECONGESTANT (PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [DISPENSING SOLUTIONS, INC.]1
MethylparabenINACTIVE INGREDIENTA2I8C7HI9TRUGBY (PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [RUGBY LABORATORIES, INC.]1
RaspberryINACTIVE INGREDIENT4N14V5R27WRUGBY NASAL DECONGESTANT NASAL DECONGESTANT (PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [DISPENSING SOLUTIONS, INC.]1
RaspberryINACTIVE INGREDIENT4N14V5R27WRUGBY (PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [RUGBY LABORATORIES, INC.]1
Saccharin SodiumINACTIVE INGREDIENTSB8ZUX40TYRUGBY NASAL DECONGESTANT NASAL DECONGESTANT (PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [DISPENSING SOLUTIONS, INC.]1
Saccharin SodiumINACTIVE INGREDIENTSB8ZUX40TYRUGBY (PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [RUGBY LABORATORIES, INC.]1
Sodium BenzoateINACTIVE INGREDIENTOJ245FE5EURUGBY (PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [RUGBY LABORATORIES, INC.]1
Sodium BenzoateINACTIVE INGREDIENTOJ245FE5EURUGBY NASAL DECONGESTANT NASAL DECONGESTANT (PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [DISPENSING SOLUTIONS, INC.]1
SorbitolINACTIVE INGREDIENT506T60A25RRUGBY NASAL DECONGESTANT NASAL DECONGESTANT (PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [DISPENSING SOLUTIONS, INC.]1
SorbitolINACTIVE INGREDIENT506T60A25RRUGBY (PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [RUGBY LABORATORIES, INC.]1
WaterINACTIVE INGREDIENT059QF0KO0RRUGBY NASAL DECONGESTANT NASAL DECONGESTANT (PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [DISPENSING SOLUTIONS, INC.]1
WaterINACTIVE INGREDIENT059QF0KO0RRUGBY (PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [RUGBY LABORATORIES, INC.]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049163pseudoephedrine HCl 30 MG in 5 mL Oral SolutionPSN403f5679-f1ad-4e84-962d-3ad1964960b110
1049163pseudoephedrine hydrochloride 6 MG/ML Oral SolutionSCD403f5679-f1ad-4e84-962d-3ad1964960b110
1049163pseudoephedrine hydrochloride 30 MG per 5 ML Oral SolutionSY403f5679-f1ad-4e84-962d-3ad1964960b110
1049163pseudoephedrine HCl 30 MG in 5 mL Oral SolutionPSN8cce0ece-0589-4894-8fd7-bba40eedaa521
1049163pseudoephedrine hydrochloride 6 MG/ML Oral SolutionSCD8cce0ece-0589-4894-8fd7-bba40eedaa521
1049163pseudoephedrine hydrochloride 30 MG per 5 ML Oral SolutionSY8cce0ece-0589-4894-8fd7-bba40eedaa521