Home NDC 42291-244-04 Donnatal
Product NDC 42291-244
Requested package NDC 42291-244-04
11-digit product format 422910244
Labeler code 42291
Product ID 42291-244_9220ec2f-2897-25b7-e053-2995a90a4e05
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name phenobarbital elixir
Dosage form ELIXIR
Route ORAL
Labeler AvKARE, Inc
Marketing category UNAPPROVED DRUG OTHER
Marketing start 2014-01-13
Marketing end 0000-00-00
Substance PHENOBARBITAL; HYOSCYAMINE SULFATE; ATROPINE SULFATE; SCOPOLAMINE HYDROBROMIDE
Active strength 16 mg/5mL; mg/5mL; mg/5mL; mg/5mL
Pharmacologic classes Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA],Anticholinergic [EPC],Cholinergic Antagonists [MoA]
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 · 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 Atropine sulfate ACTIVE INGREDIENT 03J5ZE7KA5 DONNATAL (PHENOBARBITAL ELIXIR) ELIXIR [AVKARE, INC.] 3 Hyoscyamine sulfate ACTIVE INGREDIENT F2R8V82B84 DONNATAL (PHENOBARBITAL ELIXIR) ELIXIR [AVKARE, INC.] 3 Phenobarbital ACTIVE INGREDIENT YQE403BP4D DONNATAL (PHENOBARBITAL ELIXIR) ELIXIR [AVKARE, INC.] 3 Scopolamine hydrobromide ACTIVE INGREDIENT 451IFR0GXB DONNATAL (PHENOBARBITAL ELIXIR) ELIXIR [AVKARE, INC.] 3 Atropine ACTIVE MOIETY 7C0697DR9I DONNATAL (PHENOBARBITAL ELIXIR) ELIXIR [AVKARE, INC.] 3 Hyoscyamine ACTIVE MOIETY PX44XO846X DONNATAL (PHENOBARBITAL ELIXIR) ELIXIR [AVKARE, INC.] 3 Phenobarbital ACTIVE MOIETY YQE403BP4D DONNATAL (PHENOBARBITAL ELIXIR) ELIXIR [AVKARE, INC.] 3 Scopolamine ACTIVE MOIETY DL48G20X8X DONNATAL (PHENOBARBITAL ELIXIR) ELIXIR [AVKARE, INC.] 3 alcohol INACTIVE INGREDIENT 3K9958V90M DONNATAL (PHENOBARBITAL ELIXIR) ELIXIR [AVKARE, INC.] 3 FD&C Blue No. 1 INACTIVE INGREDIENT H3R47K3TBD DONNATAL (PHENOBARBITAL ELIXIR) ELIXIR [AVKARE, INC.] 3 FD&C Red No. 3 INACTIVE INGREDIENT PN2ZH5LOQY DONNATAL (PHENOBARBITAL ELIXIR) ELIXIR [AVKARE, INC.] 3 Glycerin INACTIVE INGREDIENT PDC6A3C0OX DONNATAL (PHENOBARBITAL ELIXIR) ELIXIR [AVKARE, INC.] 3 GRAPE INACTIVE INGREDIENT 6X543N684K DONNATAL (PHENOBARBITAL ELIXIR) ELIXIR [AVKARE, INC.] 3 saccharin sodium INACTIVE INGREDIENT SB8ZUX40TY DONNATAL (PHENOBARBITAL ELIXIR) ELIXIR [AVKARE, INC.] 3 sorbitol INACTIVE INGREDIENT 506T60A25R DONNATAL (PHENOBARBITAL ELIXIR) ELIXIR [AVKARE, INC.] 3 sucrose INACTIVE INGREDIENT C151H8M554 DONNATAL (PHENOBARBITAL ELIXIR) ELIXIR [AVKARE, INC.] 3 water INACTIVE INGREDIENT 059QF0KO0R DONNATAL (PHENOBARBITAL ELIXIR) ELIXIR [AVKARE, 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 42291-244-04 42291024404 118 mL in 1 BOTTLE (42291-244-04) 118 ml 2014-02-04 0000-00-00 No No Current