Home NDC 45014-158 Daytime Cough and Cold
Product NDC 45014-158
11-digit product format 450140158
Labeler code 45014
Product ID 45014-158_97558c3c-84f5-4185-8462-a113bd2e3be8
Type HUMAN OTC DRUG
Nonproprietary name Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride
Dosage form SOLUTION
Route ORAL
Labeler Accudial Pharmaceutical, Inc.
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2013-02-01
Marketing end 0000-00-00
Substance DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength 5 mg/5mL; mg/5mL
NDC exclude flag E
Listing certified through 2017-12-31
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 · 44 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 45014-158-04 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 45014-158-04 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 45014-158-04 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 45014-158-04 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 45014-158-04 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 45014-158-04 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 45014-158-04 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 45014-158-04 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 45014-158-04 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 45014-158-04 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 45014-158-04 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 45014-158-04 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 45014-158-04 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 45014-158-04 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 45014-158-04 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 45014-158-04 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 45014-158-04 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 45014-158-04 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 45014-158-04 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 45014-158-04 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 45014-158-04 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 45014-158-04 110d247fa046…a55b01930146…
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 45014-158-04 Daytime Cough and Cold 118 mL in 1 BOTTLE SOLUTION 118 1
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Dextromethorphan Hydrobromide ACTIVE INGREDIENT 9D2RTI9KYH DAYTIME COUGH AND COLD (DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [ACCUDIAL PHARMACEUTICAL, INC.] 1 Phenylephrine Hydrochloride ACTIVE INGREDIENT 04JA59TNSJ DAYTIME COUGH AND COLD (DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [ACCUDIAL PHARMACEUTICAL, INC.] 1 Dextromethorphan ACTIVE MOIETY 7355X3ROTS DAYTIME COUGH AND COLD (DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [ACCUDIAL PHARMACEUTICAL, INC.] 1 Phenylephrine ACTIVE MOIETY 1WS297W6MV DAYTIME COUGH AND COLD (DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [ACCUDIAL PHARMACEUTICAL, INC.] 1 Benzoic Acid INACTIVE INGREDIENT 8SKN0B0MIM DAYTIME COUGH AND COLD (DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [ACCUDIAL PHARMACEUTICAL, INC.] 1 Citric Acid Monohydrate INACTIVE INGREDIENT 2968PHW8QP DAYTIME COUGH AND COLD (DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [ACCUDIAL PHARMACEUTICAL, INC.] 1 Edetate Disodium INACTIVE INGREDIENT 7FLD91C86K DAYTIME COUGH AND COLD (DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [ACCUDIAL PHARMACEUTICAL, INC.] 1 FD&C Red No. 40 INACTIVE INGREDIENT WZB9127XOA DAYTIME COUGH AND COLD (DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [ACCUDIAL PHARMACEUTICAL, INC.] 1 Propylene Glycol INACTIVE INGREDIENT 6DC9Q167V3 DAYTIME COUGH AND COLD (DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [ACCUDIAL PHARMACEUTICAL, INC.] 1 Saccharin Sodium INACTIVE INGREDIENT SB8ZUX40TY DAYTIME COUGH AND COLD (DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [ACCUDIAL PHARMACEUTICAL, INC.] 1 Sodium Citrate INACTIVE INGREDIENT 1Q73Q2JULR DAYTIME COUGH AND COLD (DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [ACCUDIAL PHARMACEUTICAL, INC.] 1 Sorbitol INACTIVE INGREDIENT 506T60A25R DAYTIME COUGH AND COLD (DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [ACCUDIAL PHARMACEUTICAL, INC.] 1 Water INACTIVE INGREDIENT 059QF0KO0R DAYTIME COUGH AND COLD (DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [ACCUDIAL PHARMACEUTICAL, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 45014-158 DAYTIME COUGH AND COLD (DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [ACCUDIAL PHARMACEUTICAL, INC.] 1 Legacy NDC, 1 package rows 20130209_e9e021cf-b8eb-4309-bf0b-a24334ba278e.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Status 45014-158-04 45014015804 118 mL in 1 BOTTLE 118 ml Historical