FDA.reportPublic FDA data

topcare 12 hour decongestant

Product NDC
36800-054
11-digit product format
368000054
Labeler code
36800
Product ID
36800-054_1dc8f02b-e7c0-4a83-b9f4-49d7384a7ba6
Type
HUMAN OTC DRUG
Nonproprietary name
Pseudoephedrine Hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Topco Associates LLC
Application
ANDA075153
Marketing category
ANDA
Marketing start
2000-04-25
Substance
PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength
120 mg/1
Pharmacologic classes
Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
topcare 12 hour decongestant
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PSEUDOEPHEDRINE HYDROCHLORIDE120 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6V9V2RYJ8N
Rxcui1049154

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
e974e22d-8688-7d92-1e87-40c1079e170cProduct name320151125
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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-054-52topcare 12 hour decongestant10 in 1 CARTONTABLET, FILM COATED, EXTENDED RE107
36800-054-52topcare 12 hour decongestant1 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE17
36800-054-60topcare 12 hour decongestant20 in 1 CARTONTABLET, FILM COATED, EXTENDED RE207
36800-054-60topcare 12 hour decongestant1 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
36800-054-52EA - Each36800-054206fa30b-621e-4e21-b083-f44c52daff0b12012-07-24
36800-054-60EA - Each36800-054af42d3e8-224f-491a-850e-21194e672ecb12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PSEUDOEPHEDRINE HYDROCHLORIDEACTIVE INGREDIENT6V9V2RYJ8NTOPCARE 12 HOUR DECONGESTANT (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [TOPCO ASSOCIATES LLC]2
PSEUDOEPHEDRINEACTIVE MOIETY7CUC9DDI9FTOPCARE 12 HOUR DECONGESTANT (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [TOPCO ASSOCIATES LLC]2
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPTOPCARE 12 HOUR DECONGESTANT (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [TOPCO ASSOCIATES LLC]2
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZTOPCARE 12 HOUR DECONGESTANT (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [TOPCO ASSOCIATES LLC]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTOPCARE 12 HOUR DECONGESTANT (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [TOPCO ASSOCIATES LLC]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOTOPCARE 12 HOUR DECONGESTANT (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [TOPCO ASSOCIATES LLC]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TOPCARE 12 HOUR DECONGESTANT (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [TOPCO ASSOCIATES LLC]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ATOPCARE 12 HOUR DECONGESTANT (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [TOPCO ASSOCIATES LLC]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HTOPCARE 12 HOUR DECONGESTANT (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [TOPCO ASSOCIATES LLC]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TOPCARE 12 HOUR DECONGESTANT (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [TOPCO ASSOCIATES LLC]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTOPCARE 12 HOUR DECONGESTANT (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [TOPCO ASSOCIATES LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-054TOPCARE 12 HOUR DECONGESTANT (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [TOPCO ASSOCIATES LLC]7Current NDC, Legacy NDC, 4 package rows20221101_4841c79a-fb92-4209-929a-e4ea0c4015dd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049154pseudoephedrine HCl 120 MG 12HR Extended Release Oral TabletPSN4841c79a-fb92-4209-929a-e4ea0c4015dd7
104915412 HR pseudoephedrine hydrochloride 120 MG Extended Release Oral TabletSCD4841c79a-fb92-4209-929a-e4ea0c4015dd7
1049154pseudoephedrine HCl 120 MG 12 HR Extended Release Oral TabletSY4841c79a-fb92-4209-929a-e4ea0c4015dd7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-054-523680000545210 BLISTER PACK in 1 CARTON (36800-054-52) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK10 blister pack2000-04-250000-00-00NoNoCurrent
36800-054-603680000546020 BLISTER PACK in 1 CARTON (36800-054-60) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK20 blister pack2003-05-200000-00-00NoNoCurrent