Home NDC 53807-522 Nite Time
Product NDC 53807-522
11-digit product format 538070522
Labeler code 53807
Product ID 53807-522_b7594b84-0c64-4e6f-8de5-538a9df89c5e
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Dextromethorphan Hydrobromide, and Doxylamine succinate
Dosage form LIQUID
Route ORAL
Labeler Rij Pharmaceutical Corporation
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 1999-03-16
Marketing end 0000-00-00
Substance ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
Active strength 325 mg/15mL; mg/15mL; mg/15mL
NDC exclude flag No
Listing certified through 2019-12-31
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 · 42 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 53807-522-06 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 53807-522-06 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 53807-522-06 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 53807-522-06 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 53807-522-06 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 53807-522-06 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 53807-522-06 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 53807-522-06 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 53807-522-06 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 53807-522-06 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 53807-522-06 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 53807-522-06 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 53807-522-06 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 53807-522-06 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 53807-522-06 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 53807-522-06 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 53807-522-06 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 53807-522-06 bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 53807-522-06 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 53807-522-06 e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 53807-522-06 9bebd1f3094a…5416666fcb17…
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 53807-522-06 Nite TimeCold Medicine Cherry Flavor 177 mL in 1 BOTTLE, PLASTIC LIQUID 177 2
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Acetaminophen ACTIVE INGREDIENT 362O9ITL9D NITE TIME COLD MEDICINE CHERRY FLAVOR (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE) LIQUID [RIJ PHARMACEUTICAL CORPORATION] 1 Dextromethorphan Hydrobromide ACTIVE INGREDIENT 9D2RTI9KYH NITE TIME COLD MEDICINE CHERRY FLAVOR (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE) LIQUID [RIJ PHARMACEUTICAL CORPORATION] 1 Doxylamine succinate ACTIVE INGREDIENT V9BI9B5YI2 NITE TIME COLD MEDICINE CHERRY FLAVOR (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE) LIQUID [RIJ PHARMACEUTICAL CORPORATION] 1 Acetaminophen ACTIVE MOIETY 362O9ITL9D NITE TIME COLD MEDICINE CHERRY FLAVOR (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE) LIQUID [RIJ PHARMACEUTICAL CORPORATION] 1 Dextromethorphan ACTIVE MOIETY 7355X3ROTS NITE TIME COLD MEDICINE CHERRY FLAVOR (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE) LIQUID [RIJ PHARMACEUTICAL CORPORATION] 1 Doxylamine ACTIVE MOIETY 95QB77JKPL NITE TIME COLD MEDICINE CHERRY FLAVOR (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE) LIQUID [RIJ PHARMACEUTICAL CORPORATION] 1 alcohol INACTIVE INGREDIENT 3K9958V90M NITE TIME COLD MEDICINE CHERRY FLAVOR (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE) LIQUID [RIJ PHARMACEUTICAL CORPORATION] 1 citric acid monohydrate INACTIVE INGREDIENT 2968PHW8QP NITE TIME COLD MEDICINE CHERRY FLAVOR (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE) LIQUID [RIJ PHARMACEUTICAL CORPORATION] 1 FD&C Blue No. 1 INACTIVE INGREDIENT H3R47K3TBD NITE TIME COLD MEDICINE CHERRY FLAVOR (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE) LIQUID [RIJ PHARMACEUTICAL CORPORATION] 1 FD&C Red No. 40 INACTIVE INGREDIENT WZB9127XOA NITE TIME COLD MEDICINE CHERRY FLAVOR (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE) LIQUID [RIJ PHARMACEUTICAL CORPORATION] 1 high fructose corn syrup INACTIVE INGREDIENT XY6UN3QB6S NITE TIME COLD MEDICINE CHERRY FLAVOR (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE) LIQUID [RIJ PHARMACEUTICAL CORPORATION] 1 polyethylene glycols INACTIVE INGREDIENT 3WJQ0SDW1A NITE TIME COLD MEDICINE CHERRY FLAVOR (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE) LIQUID [RIJ PHARMACEUTICAL CORPORATION] 1 propylene glycol INACTIVE INGREDIENT 6DC9Q167V3 NITE TIME COLD MEDICINE CHERRY FLAVOR (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE) LIQUID [RIJ PHARMACEUTICAL CORPORATION] 1 saccharin sodium INACTIVE INGREDIENT SB8ZUX40TY NITE TIME COLD MEDICINE CHERRY FLAVOR (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE) LIQUID [RIJ PHARMACEUTICAL CORPORATION] 1 sodium benzoate INACTIVE INGREDIENT OJ245FE5EU NITE TIME COLD MEDICINE CHERRY FLAVOR (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE) LIQUID [RIJ PHARMACEUTICAL CORPORATION] 1 sodium citrate INACTIVE INGREDIENT 1Q73Q2JULR NITE TIME COLD MEDICINE CHERRY FLAVOR (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE) LIQUID [RIJ PHARMACEUTICAL CORPORATION] 1 water INACTIVE INGREDIENT 059QF0KO0R NITE TIME COLD MEDICINE CHERRY FLAVOR (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE) LIQUID [RIJ PHARMACEUTICAL CORPORATION] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53807-522 NITE TIME COLD MEDICINE CHERRY FLAVOR (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE) LIQUID [RIJ PHARMACEUTICAL CORPORATION] 2 Legacy NDC, 1 package rows 20180502_ce5b1fae-9fcc-4283-b7e6-cb15fba13d3b.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Status 53807-522-06 53807052206 177 mL in 1 BOTTLE, PLASTIC 177 ml Historical