Meclizine HCL 25 mg

Product NDC
55700-715
Requested package NDC
55700-715-30
11-digit product format
557000715
Labeler code
55700
Product ID
55700-715_7d268b82-7559-449c-ad93-c809acd1fe76
Type
HUMAN OTC DRUG
Nonproprietary name
Meclizine HCL
Dosage form
TABLET
Route
ORAL
Labeler
Quality Care Products, LLC
Application
part336
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2019-01-04
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 · 6 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55700-715-302023-01-30C16284748780-1f386c649-d0a1-0266-e053-dadaa90a7c1aMeclizine HCL 25 mg

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55700-715-30EA - Each55700-715019fe615-4c23-479d-ab16-0d5ab2e9d92112019-02-13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55700-715-305570007153030 TABLET in 1 BOTTLE, PLASTIC (55700-715-30) 30 tablet2019-01-040000-00-00NoNoCurrent