Home NDC 59212-423-16 Donnatal
Product NDC 59212-423
Requested package NDC 59212-423-16
11-digit product format 592120423
Labeler code 59212
Product ID 59212-423_f15ad820-c07e-4e6b-a154-7ddca20bc838
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name phenobarbital, hyoscyamine sulfate, atropine sulfate, scopolamine hydrobromide
Dosage form ELIXIR
Route ORAL
Labeler Advanz Pharma (US) Corp.
Marketing category UNAPPROVED DRUG OTHER
Marketing start 1980-12-30
Substance ATROPINE SULFATE; HYOSCYAMINE SULFATE; PHENOBARBITAL; SCOPOLAMINE HYDROBROMIDE
Active strength .0194; .1037; 16.2; .0065 mg/5mL; mg/5mL; mg/5mL; mg/5mL
Pharmacologic classes Anticholinergic [EPC], Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]
DEA schedule CIV
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base Donnatal
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PHENOBARBITAL .0194 mg/5mL HYOSCYAMINE SULFATE .1037 mg/5mL ATROPINE SULFATE 16.2 mg/5mL SCOPOLAMINE HYDROBROMIDE .0065 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 4 matching rows.
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1046787 Internal RxNorm lookup 1046924 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 59212-423-04 Donnatal 118 mL in 1 BOTTLE ELIXIR 118 13 59212-423-10 Donnatal 10 mL in 1 BOTTLE ELIXIR 10 13 59212-423-16 Donnatal 473 mL in 1 BOTTLE ELIXIR 473 13
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Atropine sulfate ACTIVE INGREDIENT 03J5ZE7KA5 DONNATAL (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) ELIXIR [CONCORDIA PHARMACEUTICALS INC.] 4 Hyoscyamine sulfate ACTIVE INGREDIENT F2R8V82B84 DONNATAL (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) ELIXIR [CONCORDIA PHARMACEUTICALS INC.] 4 Phenobarbital ACTIVE INGREDIENT YQE403BP4D DONNATAL (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) ELIXIR [CONCORDIA PHARMACEUTICALS INC.] 4 Scopolamine hydrobromide ACTIVE INGREDIENT 451IFR0GXB DONNATAL (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) ELIXIR [CONCORDIA PHARMACEUTICALS INC.] 4 Atropine ACTIVE MOIETY 7C0697DR9I DONNATAL (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) ELIXIR [CONCORDIA PHARMACEUTICALS INC.] 4 Hyoscyamine ACTIVE MOIETY PX44XO846X DONNATAL (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) ELIXIR [CONCORDIA PHARMACEUTICALS INC.] 4 Phenobarbital ACTIVE MOIETY YQE403BP4D DONNATAL (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) ELIXIR [CONCORDIA PHARMACEUTICALS INC.] 4 Scopolamine ACTIVE MOIETY DL48G20X8X DONNATAL (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) ELIXIR [CONCORDIA PHARMACEUTICALS INC.] 4 alcohol INACTIVE INGREDIENT 3K9958V90M DONNATAL (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) ELIXIR [CONCORDIA PHARMACEUTICALS INC.] 4 FD&C Blue No. 1 INACTIVE INGREDIENT H3R47K3TBD DONNATAL (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) ELIXIR [CONCORDIA PHARMACEUTICALS INC.] 4 FD&C Red No. 3 INACTIVE INGREDIENT PN2ZH5LOQY DONNATAL (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) ELIXIR [CONCORDIA PHARMACEUTICALS INC.] 4 FD&C YELLOW NO. 5 INACTIVE INGREDIENT I753WB2F1M DONNATAL (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) ELIXIR [CONCORDIA PHARMACEUTICALS INC.] 4 Glycerin INACTIVE INGREDIENT PDC6A3C0OX DONNATAL (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) ELIXIR [CONCORDIA PHARMACEUTICALS INC.] 4 saccharin sodium INACTIVE INGREDIENT SB8ZUX40TY DONNATAL (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) ELIXIR [CONCORDIA PHARMACEUTICALS INC.] 4 sorbitol INACTIVE INGREDIENT 506T60A25R DONNATAL (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) ELIXIR [CONCORDIA PHARMACEUTICALS INC.] 4 sucrose INACTIVE INGREDIENT C151H8M554 DONNATAL (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) ELIXIR [CONCORDIA PHARMACEUTICALS INC.] 4 water INACTIVE INGREDIENT 059QF0KO0R DONNATAL (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) ELIXIR [CONCORDIA PHARMACEUTICALS INC.] 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59212-423 DONNATAL (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) ELIXIR [ADVANZ PHARMA (US) CORP.] 13 Current NDC, Legacy NDC, 3 package rows 20241220_4dba30db-7979-455f-a225-24f0a04d744e.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Donnatal PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE Advanz Pharma (US) Corp. 4dba30db-7979-455f-a225-24f0a04d744e 2024-12-05 Warnings, Adverse reactions Exact identifier ndc (package): 59212-423-16 ndc (product): 59212-423 ndc11 (package): 59212042316
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 59212-423-16 59212042316 473 mL in 1 BOTTLE (59212-423-16) 473 ml 1980-12-30 0000-00-00 No No Current