Histenol Forte II

Product NDC
35418-111
11-digit product format
354180111
Labeler code
35418
Product ID
35418-111_f19b94fe-7bea-319d-e053-2a95a90a74f0
Type
HUMAN OTC DRUG
Nonproprietary name
Phenylephrine HCl, Acetaminophen, Guaifenesin
Dosage form
TABLET
Route
ORAL
Labeler
Zee Medical Inc
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2012-06-12
Marketing end
2023-04-01
Substance
ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength
325 mg/1; mg/1; mg/1
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
35418-111-672023-01-06C16284748780-1ba0f9c33-51d7-a910-e053-dadaa90a0b85248e8c14-4f50-46a4-8da4-d8edc47e5aac
35418-111-672021-01-29C16284748780-1ba0f9c33-51d7-a910-e053-dadaa90a0b85248e8c14-4f50-46a4-8da4-d8edc47e5aac

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
35418-111-6735418011167125 CARTON in 1 CARTON (35418-111-67) > 50 PACKET in 1 CARTON (35418-111-68) > 2 TABLET in 1 PACKET (35418-111-02) 125 carton2012-06-122023-04-01NoNoCurrent