Home NDC 69729-152 tabcin ACTIVE
Product NDC 69729-152
11-digit product format 697290152
Labeler code 69729
Product ID 69729-152_5d345460-8406-ef2f-e063-6294a90a3f03
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler OPMX LLC.
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-11-28
Substance DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE
Active strength 10; 325; 5 mg/1; mg/1; mg/1
Pharmacologic classes Adrenergic alpha1-Agonists [MoA], 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 2027-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base tabcin ACTIVE
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEXTROMETHORPHAN HYDROBROMIDE 10 mg/1 ACETAMINOPHEN 325 mg/1 PHENYLEPHRINE HYDROCHLORIDE 5 mg/1
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 69729-152-10 tabcin ACTIVE 1 in 1 CARTON CAPSULE, LIQUID FILLED 1 3 69729-152-10 tabcin ACTIVE 10 in 1 BLISTER PACK CAPSULE, LIQUID FILLED 10 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69729-152 TABCIN ACTIVE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [OPMX LLC.] 2 Current NDC, 2 package rows 20240407_0b3eb8c3-9b9e-861b-e063-6294a90a4a0f.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 99 of 180 · 3,583 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 69729-152-10 69729015210 1 BLISTER PACK in 1 CARTON (69729-152-10) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK 1 blister pack 2023-11-28 No No Current