Home NDC 49483-356-00 TIME-GESIC
Product NDC 49483-356
Requested package NDC 49483-356-00
11-digit product format 494830356
Labeler code 49483
Product ID 49483-356_97f18e17-9dda-8bf7-e053-2995a90ae67b
Type HUMAN OTC DRUG
Nonproprietary name ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE
Dosage form TABLET, COATED
Route ORAL
Labeler Time-Cap Labs, Inc
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2012-12-18
Marketing end 0000-00-00
Substance ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE
Active strength 325 mg/1; mg/1
NDC exclude flag No
Listing certified through 2020-12-31
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 · 15 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…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…
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 49483-356-00 TIME-GESIC 100000 in 1 CARTON TABLET, COATED 100000 5 49483-356-09 TIME-GESIC 90 in 1 BOTTLE, PLASTIC TABLET, COATED 90 5
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ACETAMINOPHEN ACTIVE INGREDIENT 362O9ITL9D TIME-GESIC (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [TIME-CAP LABS, INC] 4 DIPHENHYDRAMINE HYDROCHLORIDE ACTIVE INGREDIENT TC2D6JAD40 TIME-GESIC (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [TIME-CAP LABS, INC] 4 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D TIME-GESIC (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [TIME-CAP LABS, INC] 4 DIPHENHYDRAMINE ACTIVE MOIETY 8GTS82S83M TIME-GESIC (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [TIME-CAP LABS, INC] 4 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U TIME-GESIC (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [TIME-CAP LABS, INC] 4 COLLOIDAL SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 TIME-GESIC (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [TIME-CAP LABS, INC] 4 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK TIME-GESIC (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [TIME-CAP LABS, INC] 4 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 TIME-GESIC (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [TIME-CAP LABS, INC] 4 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO TIME-GESIC (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [TIME-CAP LABS, INC] 4 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 TIME-GESIC (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [TIME-CAP LABS, INC] 4 POVIDONE INACTIVE INGREDIENT FZ989GH94E TIME-GESIC (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [TIME-CAP LABS, INC] 4 STARCH, PREGELATINIZED CORN INACTIVE INGREDIENT O8232NY3SJ TIME-GESIC (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [TIME-CAP LABS, INC] 4 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP TIME-GESIC (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [TIME-CAP LABS, INC] 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 49483-356 TIME-GESIC (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [TIME-CAP LABS, INC] 5 Legacy NDC, 2 package rows 20191123_889c5b6a-879e-425c-a25a-435766e9d601.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 49483-356-00 49483035600 100000 TABLET, COATED in 1 CARTON (49483-356-00) 2012-12-18 0000-00-00 No No Current