Home NDC 11584-1110-1 Despec
Product NDC 11584-1110
Requested package NDC 11584-1110-1
11-digit product format 115841110
Labeler code 11584
Product ID 11584-1110_78499d46-0245-544b-e053-2991aa0a69ab
Type HUMAN OTC DRUG
Nonproprietary name Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride
Dosage form LIQUID
Route ORAL
Labeler International Ethical Labs
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2012-01-19
Marketing end 0000-00-00
Substance DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength 5 mg/mL; mg/mL; mg/mL
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 · 16 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…2022-08-30 03:57 UTC · source 2022-08-29 fb8cb913e6d1…eb8c232b6be0…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 11584-1110-1 DespecEDA Drops 30 mL in 1 BOTTLE LIQUID 30 3
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Dextromethorphan Hydrobromide ACTIVE INGREDIENT 9D2RTI9KYH DESPEC EDA DROPS (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [INTERNATIONAL ETHICAL LABS] 1 Guaifenesin ACTIVE INGREDIENT 495W7451VQ DESPEC EDA DROPS (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [INTERNATIONAL ETHICAL LABS] 1 Phenylephrine Hydrochloride ACTIVE INGREDIENT 04JA59TNSJ DESPEC EDA DROPS (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [INTERNATIONAL ETHICAL LABS] 1 Dextromethorphan ACTIVE MOIETY 7355X3ROTS DESPEC EDA DROPS (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [INTERNATIONAL ETHICAL LABS] 1 Guaifenesin ACTIVE MOIETY 495W7451VQ DESPEC EDA DROPS (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [INTERNATIONAL ETHICAL LABS] 1 Phenylephrine ACTIVE MOIETY 1WS297W6MV DESPEC EDA DROPS (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [INTERNATIONAL ETHICAL LABS] 1 Citric Acid Monohydrate INACTIVE INGREDIENT 2968PHW8QP DESPEC EDA DROPS (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [INTERNATIONAL ETHICAL LABS] 1 Glycerin INACTIVE INGREDIENT PDC6A3C0OX DESPEC EDA DROPS (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [INTERNATIONAL ETHICAL LABS] 1 Propylene Glycol INACTIVE INGREDIENT 6DC9Q167V3 DESPEC EDA DROPS (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [INTERNATIONAL ETHICAL LABS] 1 Saccharin Sodium INACTIVE INGREDIENT SB8ZUX40TY DESPEC EDA DROPS (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [INTERNATIONAL ETHICAL LABS] 1 Sodium Citrate INACTIVE INGREDIENT 1Q73Q2JULR DESPEC EDA DROPS (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [INTERNATIONAL ETHICAL LABS] 1 Sorbitol INACTIVE INGREDIENT 506T60A25R DESPEC EDA DROPS (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [INTERNATIONAL ETHICAL LABS] 1 Sucralose INACTIVE INGREDIENT 96K6UQ3ZD4 DESPEC EDA DROPS (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [INTERNATIONAL ETHICAL LABS] 1 Water INACTIVE INGREDIENT 059QF0KO0R DESPEC EDA DROPS (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [INTERNATIONAL ETHICAL LABS] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 11584-1110 DESPEC EDA DROPS (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [INTERNATIONAL ETHICAL LABS] 3 Legacy NDC, 1 package rows 20181017_e8be10f5-8971-4e48-b7b9-ff77b0e43e64.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 11584-1110-1 11584111001 30 mL in 1 BOTTLE (11584-1110-1) 30 ml 2012-01-19 0000-00-00 No No Current