Twkof Children

Product NDC
69729-620
11-digit product format
697290620
Labeler code
69729
Product ID
69729-620_eaf1555d-7a3a-7ccb-e053-2995a90af62e
Type
HUMAN OTC DRUG
Nonproprietary name
Pain Reliever/fever reducer, Cough suppresant, Expectorant, Nasal decongestant
Dosage form
SYRUP
Route
ORAL
Labeler
OPMX LLC
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2022-04-22
Marketing end
0000-00-00
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength
325 mg/10mL; mg/10mL; mg/10mL; mg/10mL
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69729-620-062024-04-05C16284748780-11030e365-53a4-111a-e063-dadaa90a10e2dd4202b4-cbff-64b9-e053-2995a90aeb97
69729-620-062024-01-30C16284748780-11030e365-53a4-111a-e063-dadaa90a10e2dd4202b4-cbff-64b9-e053-2995a90aeb97

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69729-620-06697290620061 BOTTLE, DISPENSING in 1 CARTON (69729-620-06) > 177 mL in 1 BOTTLE, DISPENSING2022-04-220000-00-00NoNoCurrent