Home NDC 0031-2247-13 CHILDRENS DIMETAPP NIGHTTIME COLD AND CONGESTION
Product NDC 0031-2247
Requested package NDC 0031-2247-13
11-digit product format 000312247
Labeler code 0031
Product ID 0031-2247_8c3de1e3-e4d6-46d1-aa5b-783c3ecf89f0
Type HUMAN OTC DRUG
Nonproprietary name diphenhydramine hcl, phenylephrine hcl
Dosage form LIQUID
Route ORAL
Labeler GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2007-11-01
Marketing end 0000-00-00
Substance DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength 6 mg/5mL; mg/5mL
NDC exclude flag No
Listing certified through 2021-12-31
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 diphenhydramine hydrochloride ACTIVE INGREDIENT TC2D6JAD40 CHILDRENS DIMETAPP NIGHTTIME COLD AND CONGESTION (DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) LIQUID [RICHMOND DIVISION OF WYETH LLC, A SUBSIDIARY OF PFIZER INC.] 3 phenylephrine hydrochloride ACTIVE INGREDIENT 04JA59TNSJ CHILDRENS DIMETAPP NIGHTTIME COLD AND CONGESTION (DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) LIQUID [RICHMOND DIVISION OF WYETH LLC, A SUBSIDIARY OF PFIZER INC.] 3 diphenhydramine ACTIVE MOIETY 8GTS82S83M CHILDRENS DIMETAPP NIGHTTIME COLD AND CONGESTION (DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) LIQUID [RICHMOND DIVISION OF WYETH LLC, A SUBSIDIARY OF PFIZER INC.] 3 phenylephrine ACTIVE MOIETY 1WS297W6MV CHILDRENS DIMETAPP NIGHTTIME COLD AND CONGESTION (DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) LIQUID [RICHMOND DIVISION OF WYETH LLC, A SUBSIDIARY OF PFIZER INC.] 3
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0031-2247-13 00031224713 1 BOTTLE in 1 CARTON (0031-2247-13) > 118 mL in 1 BOTTLE 1 bottle 2007-11-01 0000-00-00 No No Current