Home NDC 49467-104-16 NAUS-EASE
Product NDC 49467-104
Requested package NDC 49467-104-16
11-digit product format 494670104
Labeler code 49467
Product ID 49467-104_f93712d1-5843-440d-8eeb-edeed5a30e05
Type HUMAN OTC DRUG
Nonproprietary name MECLIZINE HYDROCHLORIDE
Dosage form FILM, SOLUBLE
Route ORAL
Labeler Sunascen Therapeutics LLC
Application part336
Marketing category OTC MONOGRAPH FINAL
Marketing start 2012-04-16
Marketing end 0000-00-00
Substance MECLIZINE HYDROCHLORIDE
Active strength 25 mg/1
NDC exclude flag No
Listing certified through 2022-12-31
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# NDC, Effective, Related label table NDC Effective Related label 49467-104-01 2024-07-30 NAUS-EASE® (Meclizine Hydrochloride), USP; Film, Soluble - Product Information 49467-104-16 2024-07-30 NAUS-EASE® (Meclizine Hydrochloride), USP; Film, Soluble - Product Information 49467-104-01 2024-01-30 NAUS-EASE® (Meclizine Hydrochloride), USP; Film, Soluble - Product Information 49467-104-16 2024-01-30 NAUS-EASE® (Meclizine Hydrochloride), USP; Film, Soluble - Product Information 49467-104-01 2023-02-09 NAUS-EASE® (Meclizine Hydrochloride), USP; Film, Soluble - Product Information 49467-104-16 2023-02-09 NAUS-EASE® (Meclizine Hydrochloride), USP; Film, Soluble - Product Information 49467-104-01 2023-01-30 NAUS-EASE® (Meclizine Hydrochloride), USP; Film, Soluble - Product Information 49467-104-16 2023-01-30 NAUS-EASE® (Meclizine Hydrochloride), USP; Film, Soluble - Product Information
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 49467-104-01 NAUS-EASE 8 in 1 CARTON FILM, SOLUBLE 8 16 49467-104-01 NAUS-EASE 1 in 1 POUCH FILM, SOLUBLE 1 16 49467-104-16 NAUS-EASE 1 in 1 POUCH FILM, SOLUBLE 1 16 49467-104-16 NAUS-EASE 16 in 1 CARTON FILM, SOLUBLE 16 16
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded MECLIZINE HYDROCHLORIDE ACTIVE INGREDIENT HDP7W44CIO NAUS-EASE (MECLIZINE HYDROCHLORIDE) FILM, SOLUBLE [SUNASCEN THERAPEUTICS LLC] 7 MECLIZINE ACTIVE MOIETY 3L5TQ84570 NAUS-EASE (MECLIZINE HYDROCHLORIDE) FILM, SOLUBLE [SUNASCEN THERAPEUTICS LLC] 7 ACESULFAME POTASSIUM INACTIVE INGREDIENT 23OV73Q5G9 NAUS-EASE (MECLIZINE HYDROCHLORIDE) FILM, SOLUBLE [SUNASCEN THERAPEUTICS LLC] 7 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL NAUS-EASE (MECLIZINE HYDROCHLORIDE) FILM, SOLUBLE [SUNASCEN THERAPEUTICS LLC] 7 ANHYDROUS TRISODIUM CITRATE INACTIVE INGREDIENT RS7A450LGA NAUS-EASE (MECLIZINE HYDROCHLORIDE) FILM, SOLUBLE [SUNASCEN THERAPEUTICS LLC] 7 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO NAUS-EASE (MECLIZINE HYDROCHLORIDE) FILM, SOLUBLE [SUNASCEN THERAPEUTICS LLC] 7 MALTITOL INACTIVE INGREDIENT D65DG142WK NAUS-EASE (MECLIZINE HYDROCHLORIDE) FILM, SOLUBLE [SUNASCEN THERAPEUTICS LLC] 7 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A NAUS-EASE (MECLIZINE HYDROCHLORIDE) FILM, SOLUBLE [SUNASCEN THERAPEUTICS LLC] 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 49467-104 NAUS-EASE (MECLIZINE HYDROCHLORIDE) FILM, SOLUBLE [SUNASCEN THERAPEUTICS LLC] 16 Legacy NDC, 4 package rows 20230211_45ed34ea-457f-4d7e-8d2f-2c3ff5054a87.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 49467-104-16 49467010416 16 POUCH in 1 CARTON (49467-104-16) > 1 FILM, SOLUBLE in 1 POUCH 16 pouch 2012-04-16 0000-00-00 No No Current