Home NDC 63824-112-08 Delsym
Product NDC 63824-112
Requested package NDC 63824-112-08
11-digit product format 638240112
Labeler code 63824
Product ID 63824-112_dc5c49d8-9fdb-4d72-a6dd-cb54a3716cf0
Type HUMAN OTC DRUG
Nonproprietary name acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride
Dosage form POWDER, FOR SOLUTION
Route ORAL
Labeler RB Health (US) LLC
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2014-04-01
Marketing end 0000-00-00
Substance ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength 650 mg/1; mg/1; mg/1; mg/1
NDC exclude flag No
Listing certified through 2023-12-31
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.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded acetaminophen ACTIVE INGREDIENT 362O9ITL9D DELSYM COUGH PLUS COLD DAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [RECKITT BENCKISER LLC] 1 dextromethorphan hydrobromide ACTIVE INGREDIENT 9D2RTI9KYH DELSYM COUGH PLUS COLD DAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [RECKITT BENCKISER LLC] 1 guaifenesin ACTIVE INGREDIENT 495W7451VQ DELSYM COUGH PLUS COLD DAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [RECKITT BENCKISER LLC] 1 phenylephrine hydrochloride ACTIVE INGREDIENT 04JA59TNSJ DELSYM COUGH PLUS COLD DAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [RECKITT BENCKISER LLC] 1 acetaminophen ACTIVE MOIETY 362O9ITL9D DELSYM COUGH PLUS COLD DAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [RECKITT BENCKISER LLC] 1 dextromethorphan ACTIVE MOIETY 7355X3ROTS DELSYM COUGH PLUS COLD DAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [RECKITT BENCKISER LLC] 1 guaifenesin ACTIVE MOIETY 495W7451VQ DELSYM COUGH PLUS COLD DAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [RECKITT BENCKISER LLC] 1 phenylephrine ACTIVE MOIETY 1WS297W6MV DELSYM COUGH PLUS COLD DAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [RECKITT BENCKISER LLC] 1 anhydrous citric acid INACTIVE INGREDIENT XF417D3PSL DELSYM COUGH PLUS COLD DAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [RECKITT BENCKISER LLC] 1 aspartame INACTIVE INGREDIENT Z0H242BBR1 DELSYM COUGH PLUS COLD DAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [RECKITT BENCKISER LLC] 1 D&C Yellow No. 10 INACTIVE INGREDIENT 35SW5USQ3G DELSYM COUGH PLUS COLD DAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [RECKITT BENCKISER LLC] 1 FD&C Red No. 40 INACTIVE INGREDIENT WZB9127XOA DELSYM COUGH PLUS COLD DAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [RECKITT BENCKISER LLC] 1 saccharin sodium INACTIVE INGREDIENT SB8ZUX40TY DELSYM COUGH PLUS COLD DAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [RECKITT BENCKISER LLC] 1 sucrose INACTIVE INGREDIENT C151H8M554 DELSYM COUGH PLUS COLD DAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [RECKITT BENCKISER LLC] 1 trisodium citrate dihydrate INACTIVE INGREDIENT B22547B95K DELSYM COUGH PLUS COLD DAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [RECKITT BENCKISER LLC] 1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 63824-112-08 63824011208 8 POWDER, FOR SOLUTION in 1 CARTON (63824-112-08) 2014-04-01 0000-00-00 No No Current