Home NDC 63824-211-66 Delsym
Product NDC 63824-211
Requested package NDC 63824-211-66
11-digit product format 638240211
Labeler code 63824
Product ID 63824-211_a2bf4338-2860-4b3d-a7d3-383c407c470a
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Diphenhydramine Hydrochloride, and Phenylephrine Hydrochloride
Dosage form SOLUTION
Route ORAL
Labeler RB Health (US) LLC
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2013-03-01
Marketing end 0000-00-00
Substance ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength 650 mg/20mL; mg/20mL; mg/20mL
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 · 12 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…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Acetaminophen ACTIVE INGREDIENT 362O9ITL9D DELSYM COUGH PLUS COLD NIGHT TIME (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [RECKITT BENCKISER LLC] 2 Diphenhydramine Hydrochloride ACTIVE INGREDIENT TC2D6JAD40 DELSYM COUGH PLUS COLD NIGHT TIME (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [RECKITT BENCKISER LLC] 2 Phenylephrine Hydrochloride ACTIVE INGREDIENT 04JA59TNSJ DELSYM COUGH PLUS COLD NIGHT TIME (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [RECKITT BENCKISER LLC] 2 Acetaminophen ACTIVE MOIETY 362O9ITL9D DELSYM COUGH PLUS COLD NIGHT TIME (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [RECKITT BENCKISER LLC] 2 Diphenhydramine ACTIVE MOIETY 8GTS82S83M DELSYM COUGH PLUS COLD NIGHT TIME (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [RECKITT BENCKISER LLC] 2 Phenylephrine ACTIVE MOIETY 1WS297W6MV DELSYM COUGH PLUS COLD NIGHT TIME (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [RECKITT BENCKISER LLC] 2 anhydrous citric acid INACTIVE INGREDIENT XF417D3PSL DELSYM COUGH PLUS COLD NIGHT TIME (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [RECKITT BENCKISER LLC] 2 edetate disodium INACTIVE INGREDIENT 7FLD91C86K DELSYM COUGH PLUS COLD NIGHT TIME (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [RECKITT BENCKISER LLC] 2 FD&C Blue No. 1 INACTIVE INGREDIENT H3R47K3TBD DELSYM COUGH PLUS COLD NIGHT TIME (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [RECKITT BENCKISER LLC] 2 FD&C Red No. 40 INACTIVE INGREDIENT WZB9127XOA DELSYM COUGH PLUS COLD NIGHT TIME (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [RECKITT BENCKISER LLC] 2 glycerin INACTIVE INGREDIENT PDC6A3C0OX DELSYM COUGH PLUS COLD NIGHT TIME (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [RECKITT BENCKISER LLC] 2 propyl gallate INACTIVE INGREDIENT 8D4SNN7V92 DELSYM COUGH PLUS COLD NIGHT TIME (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [RECKITT BENCKISER LLC] 2 propylene glycol INACTIVE INGREDIENT 6DC9Q167V3 DELSYM COUGH PLUS COLD NIGHT TIME (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [RECKITT BENCKISER LLC] 2 sodium benzoate INACTIVE INGREDIENT OJ245FE5EU DELSYM COUGH PLUS COLD NIGHT TIME (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [RECKITT BENCKISER LLC] 2 sorbitol INACTIVE INGREDIENT 506T60A25R DELSYM COUGH PLUS COLD NIGHT TIME (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [RECKITT BENCKISER LLC] 2 sucralose INACTIVE INGREDIENT 96K6UQ3ZD4 DELSYM COUGH PLUS COLD NIGHT TIME (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [RECKITT BENCKISER LLC] 2 trisodium citrate dihydrate INACTIVE INGREDIENT B22547B95K DELSYM COUGH PLUS COLD NIGHT TIME (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [RECKITT BENCKISER LLC] 2 water INACTIVE INGREDIENT 059QF0KO0R DELSYM COUGH PLUS COLD NIGHT TIME (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [RECKITT BENCKISER LLC] 2 xanthan gum INACTIVE INGREDIENT TTV12P4NEE DELSYM COUGH PLUS COLD NIGHT TIME (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [RECKITT BENCKISER LLC] 2
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 63824-211-66 63824021166 180 mL in 1 BOTTLE (63824-211-66) 180 ml 2013-03-01 0000-00-00 No No Current