Daytime Severe Cold and Flu Relief Softgels

Product NDC
36800-655
11-digit product format
368000655
Labeler code
36800
Product ID
36800-655_ee280dce-f8e3-0db4-e053-2995a90ac350
Type
HUMAN OTC DRUG
Nonproprietary name
ACETAMINOHPEN, DEXTROMETHORPHAN HBr, Guaifenesin, PHENYLEPHRINE HCl
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
TopCo Associates LLC
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2019-10-31
Marketing end
0000-00-00
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength
325 mg/1; mg/1; mg/1; mg/1
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-655-24Daytime Severe Cold and Flu Relief Softgels2 in 1 CARTONCAPSULE, LIQUID FILLED27
36800-655-24Daytime Severe Cold and Flu Relief Softgels12 in 1 BLISTER PACKCAPSULE, LIQUID FILLED127

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-655DAYTIME SEVERE COLD AND FLU RELIEF SOFTGELS (ACETAMINOHPEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [TOPCO ASSOCIATES LLC]7Legacy NDC, 2 package rows20241222_a15b40ef-cbd8-426e-a23d-37f30673f05f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1656815acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral CapsulePSNa15b40ef-cbd8-426e-a23d-37f30673f05f7
1656815acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSCDa15b40ef-cbd8-426e-a23d-37f30673f05f7
1656815APAP 325 MG / Dextromethorphan Hydrobromide 10 MG / Guaifenesin 200 MG / Phenylephrine Hydrochloride 5 MG Oral CapsuleSYa15b40ef-cbd8-426e-a23d-37f30673f05f7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-655-24368000655242 BLISTER PACK in 1 CARTON (36800-655-24) > 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK2 blister pack2019-10-310000-00-00NoNoCurrent