Home NDC 64616-041 Cold and Infection Defense
Product NDC 64616-041
11-digit product format 646160041
Labeler code 64616
Product ID 64616-041_f1137cda-1bc9-1e64-e053-2995a90a8e7f
Type HUMAN OTC DRUG
Nonproprietary name Nasal Throat Spray
Dosage form LIQUID
Route NASAL
Labeler Vitality Works, Inc
Marketing category UNAPPROVED HOMEOPATHIC
Marketing start 2003-12-16
Marketing end 0000-00-00
Substance BELLADONNA LEAF; ECHINACEA PURPUREA; ECHINACEA PURPUREA ROOT
Active strength 5 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
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 · 30 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 64616-041-01 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 64616-041-01 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 64616-041-01 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 64616-041-01 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 64616-041-01 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 64616-041-01 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 64616-041-01 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 64616-041-01 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 64616-041-01 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 64616-041-01 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 64616-041-01 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 64616-041-01 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 64616-041-01 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 64616-041-01 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 64616-041-01 1332a3947898…d4bfe170f9cd…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 64616-041-01 Cold and Infection Defense 30 mL in 1 BOTTLE, SPRAY LIQUID 30 5
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded BELLADONNA LEAF ACTIVE INGREDIENT 6GZW20TIOI COLD AND INFECTION DEFENSE (NASAL THROAT SPRAY) LIQUID [VITALITY WORKS, INC] 1 ECHINACEA PURPUREA ACTIVE INGREDIENT QI7G114Y98 COLD AND INFECTION DEFENSE (NASAL THROAT SPRAY) LIQUID [VITALITY WORKS, INC] 1 ECHINACEA PURPUREA ROOT ACTIVE INGREDIENT OS64WTR4KU COLD AND INFECTION DEFENSE (NASAL THROAT SPRAY) LIQUID [VITALITY WORKS, INC] 1 BELLADONNA LEAF ACTIVE MOIETY 6GZW20TIOI COLD AND INFECTION DEFENSE (NASAL THROAT SPRAY) LIQUID [VITALITY WORKS, INC] 1 ECHINACEA PURPUREA ACTIVE MOIETY QI7G114Y98 COLD AND INFECTION DEFENSE (NASAL THROAT SPRAY) LIQUID [VITALITY WORKS, INC] 1 ECHINACEA PURPUREA ROOT ACTIVE MOIETY OS64WTR4KU COLD AND INFECTION DEFENSE (NASAL THROAT SPRAY) LIQUID [VITALITY WORKS, INC] 1 CITRUS PARADISI SEED INACTIVE INGREDIENT 12F08874Y7 COLD AND INFECTION DEFENSE (NASAL THROAT SPRAY) LIQUID [VITALITY WORKS, INC] 1 SILVER INACTIVE INGREDIENT 3M4G523W1G COLD AND INFECTION DEFENSE (NASAL THROAT SPRAY) LIQUID [VITALITY WORKS, INC] 1 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X COLD AND INFECTION DEFENSE (NASAL THROAT SPRAY) LIQUID [VITALITY WORKS, INC] 1 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I COLD AND INFECTION DEFENSE (NASAL THROAT SPRAY) LIQUID [VITALITY WORKS, INC] 1 WATER INACTIVE INGREDIENT 059QF0KO0R COLD AND INFECTION DEFENSE (NASAL THROAT SPRAY) LIQUID [VITALITY WORKS, INC] 1 XYLITOL INACTIVE INGREDIENT VCQ006KQ1E COLD AND INFECTION DEFENSE (NASAL THROAT SPRAY) LIQUID [VITALITY WORKS, INC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 64616-041 COLD AND INFECTION DEFENSE (NASAL THROAT SPRAY) LIQUID [VITALITY WORKS, INC] 5 Legacy NDC, 1 package rows 20230101_56eb5ea4-e524-42e5-bf87-48591befab8b.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 64616-041-01 64616004101 30 mL in 1 BOTTLE, SPRAY (64616-041-01) 30 ml 2003-12-16 0000-00-00 No No Current