Home NDC 82706-016 AXIV NightTime
Product NDC 82706-016
11-digit product format 827060016
Labeler code 82706
Product ID 82706-016_3f047bdc-549e-c77b-e063-6394a90ae7ad
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler VIVUNT PHARMA LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-03-07
Substance ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
Active strength 325; 15; 6.25 mg/1; mg/1; mg/1
Pharmacologic classes Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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 AXIV NightTime
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 325 mg/1 DEXTROMETHORPHAN HYDROBROMIDE 15 mg/1 DOXYLAMINE SUCCINATE 6.25 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 362O9ITL9D Internal UNII lookup 9D2RTI9KYH Internal UNII lookup V9BI9B5YI2 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1094549 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 82706-016-01 AXIV NightTime 3 in 1 CARTON CAPSULE, LIQUID FILLED 3 5 82706-016-01 AXIV NightTime 8 in 1 BLISTER PACK CAPSULE, LIQUID FILLED 8 5 82706-016-02 AXIV NightTime 2 in 1 POUCH CAPSULE, LIQUID FILLED 2 5 82706-016-02 AXIV NightTime 2 in 1 CARTON CAPSULE, LIQUID FILLED 2 5 82706-016-03 AXIV NightTime 50 in 1 CARTON CAPSULE, LIQUID FILLED 50 5 82706-016-03 AXIV NightTime 2 in 1 POUCH CAPSULE, LIQUID FILLED 2 5 82706-016-04 AXIV NightTime 25 in 1 BLISTER PACK CAPSULE, LIQUID FILLED 25 5 82706-016-04 AXIV NightTime 25 in 1 CARTON CAPSULE, LIQUID FILLED 25 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 82706-016 AXIV NIGHTTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) CAPSULE, LIQUID FILLED [VIVUNT PHARMA LLC] 4 Current NDC, 8 package rows 20250215_131f6314-c9a1-7af3-e063-6294a90abe6f.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 74 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 82706-016-01 82706001601 3 BLISTER PACK in 1 CARTON (82706-016-01) / 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK 3 blister pack 2024-03-07 No No Current 82706-016-02 82706001602 2 in 1 POUCH Historical 82706-016-03 82706001603 50 POUCH in 1 CARTON (82706-016-03) / 2 CAPSULE, LIQUID FILLED in 1 POUCH 50 pouch 2024-07-05 No No Current 82706-016-04 82706001604 25 BLISTER PACK in 1 CARTON (82706-016-04) / 25 CAPSULE, LIQUID FILLED in 1 BLISTER PACK 25 blister pack 2025-02-12 No No Current