Home NDC 61787-516-04 Diabetic Tussin Nighttime Cold and Flu
Product NDC 61787-516
Requested package NDC 61787-516-04
11-digit product format 617870516
Labeler code 61787
Product ID 61787-516_3f09d224-c1f3-43fc-a177-c3d4d84ae725
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Dextromethorphan HBr, and Diphenhydramine HCl
Dosage form LIQUID
Route ORAL
Labeler MEDTECH PRODUCTS INC
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2020-02-01
Marketing end 0000-00-00
Substance ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DIPHENHYDRAMINE HYDROCHLORIDE
Active strength 650 mg/10mL; mg/10mL; mg/10mL
Pharmacologic classes Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], 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 2023-12-31
Current FDA listing Historical FDA.report record 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 · 11 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…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 61787-516-04 Diabetic Tussin Nighttime Cold and Flu 118 mL in 1 BOTTLE LIQUID 118 3 61787-516-04 Diabetic Tussin Nighttime Cold and Flu 1 in 1 CARTON LIQUID 1 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 61787-516 DIABETIC TUSSIN NIGHTTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, AND DIPHENHYDRAMINE HCL) LIQUID [MEDTECH PRODUCTS INC] 3 Legacy NDC, 2 package rows 20220303_4d5e317f-0e32-4cdc-b56e-b792efa972f5.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 61787-516-04 61787051604 1 BOTTLE in 1 CARTON (61787-516-04) > 118 mL in 1 BOTTLE 1 bottle 2020-02-01 0000-00-00 No No Current