Donnatal

Product NDC: 66213-422
11-digit product format: 662130422
Labeler code: 66213
Product ID: 66213-422_fcbb3938-fca3-4ed6-96e4-446b7cdef5d6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: phenobarbital elixir
Dosage form: ELIXIR
Route: ORAL
Labeler: PBM Pharmaceuticals Inc.
Marketing category: UNAPPROVED DRUG OTHER
Marketing start: 2011-07-01
Marketing end: 0000-00-00
Substance: PHENOBARBITAL; HYOSCYAMINE SULFATE; SCOPOLAMINE HYDROBROMIDE; ATROPINE SULFATE
Active strength: 16 mg/5mL; mg/5mL; mg/5mL; mg/5mL
Pharmacologic classes: Anticholinergic [EPC],Cholinergic Antagonists [MoA],Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA]
NDC exclude flag: E
Listing certified through: 2017-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	66213-422		I	Inactivated by FDA	2026-10-05
excluded product	product	66213-422		I	Inactivated by FDA	2026-10-05
excluded package	package	66213-422	66213-422-04	I	Inactivated by FDA	2026-10-05
excluded package	package	66213-422	66213-422-16	I	Inactivated by FDA	2026-10-05

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 2 · 88 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	66213-422-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	66213-422-16	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	66213-422-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	66213-422-16	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	66213-422-04	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	66213-422-16	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	66213-422-04	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	66213-422-16	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	66213-422-04	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	66213-422-16	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	66213-422-04	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	66213-422-16	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	66213-422-04	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	66213-422-16	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	66213-422-04	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	66213-422-16	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	66213-422-04	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	66213-422-16	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	66213-422-04	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	66213-422-16	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	66213-422-04	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	66213-422-16	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	66213-422-04	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	66213-422-16	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	66213-422-04	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	66213-422-16	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	66213-422-04	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	66213-422-16	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	66213-422-04	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	66213-422-16	`1332a3947898…`	`d4bfe170f9cd…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6c78bd43-efb4-4aeb-b7d8-eff1532f7822	Product name	4	20250801
41231c1e-8789-4da7-ac52-77fa90a85bf5	Product name	2	20250304
fe8ea78e-e1a4-44bf-a6b2-42eed76976bb	Product name	5	20250218
e77ab9a2-80cf-4832-bff0-469bbc7cbcd0	Product name	2	20250214
5f84b7a7-523a-f042-dffb-1dadcd9b2407	Product name	4	20240110
e3e67a66-d325-4d80-8f9d-059e736d7b00	Product name	1	20230912
0cbc6fb2-78c0-4b88-98f0-a4cc76ff95ca	Product name	1	20230719
04cd5dc0-102f-46cb-8dbc-ca38dd2628d0	Product name	3	20230317
dfd25202-b8d2-4628-9213-f3e0f9eafce5	Product name	4	20210513
4199bf9b-4718-828a-6dd6-ac2fbbd61687	Product name	1	20140508
4edd8af5-cea7-ae42-8023-e91c5335db1d	Product name	1	20140508
d3908afb-7784-440f-c406-88294732d36a	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
66213-422-04	2019-11-27	C162847	48780-1	9855e2a2-4a9a-60a7-e053-dbdaa90a05bd	Donnatal Elixir Mint 4 oz
66213-422-16	2019-11-27	C162847	48780-1	9855e2a2-37b6-60a7-e053-dbdaa90a05bd	Donnatal Elixir Mint 16 oz

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
66213-422-16	Donnatal	470 mL in 1 BOTTLE	ELIXIR	470		4
66213-422-04	Donnatal	118 mL in 1 BOTTLE	ELIXIR	118		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
66213-422-04	ML - Milliliter	66213-422	183dc367-8610-4b07-819c-7ff867d266f1	1	2012-07-24
66213-422-16	ML - Milliliter	66213-422	5dda22b3-3cd0-42d0-ad80-85fb2bbe291d	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Atropine sulfate	ACTIVE INGREDIENT	03J5ZE7KA5	DONNATAL (PHENOBARBITAL ELIXIR) ELIXIR [PBM PHARMACEUTICALS INC.]	4
Hyoscyamine sulfate	ACTIVE INGREDIENT	F2R8V82B84	DONNATAL (PHENOBARBITAL ELIXIR) ELIXIR [PBM PHARMACEUTICALS INC.]	4
Phenobarbital	ACTIVE INGREDIENT	YQE403BP4D	DONNATAL (PHENOBARBITAL ELIXIR) ELIXIR [PBM PHARMACEUTICALS INC.]	4
Scopolamine hydrobromide	ACTIVE INGREDIENT	451IFR0GXB	DONNATAL (PHENOBARBITAL ELIXIR) ELIXIR [PBM PHARMACEUTICALS INC.]	4
Atropine	ACTIVE MOIETY	7C0697DR9I	DONNATAL (PHENOBARBITAL ELIXIR) ELIXIR [PBM PHARMACEUTICALS INC.]	4
Hyoscyamine	ACTIVE MOIETY	PX44XO846X	DONNATAL (PHENOBARBITAL ELIXIR) ELIXIR [PBM PHARMACEUTICALS INC.]	4
Phenobarbital	ACTIVE MOIETY	YQE403BP4D	DONNATAL (PHENOBARBITAL ELIXIR) ELIXIR [PBM PHARMACEUTICALS INC.]	4
Scopolamine	ACTIVE MOIETY	DL48G20X8X	DONNATAL (PHENOBARBITAL ELIXIR) ELIXIR [PBM PHARMACEUTICALS INC.]	4
alcohol	INACTIVE INGREDIENT	3K9958V90M	DONNATAL (PHENOBARBITAL ELIXIR) ELIXIR [PBM PHARMACEUTICALS INC.]	4
FD&C Blue No. 1	INACTIVE INGREDIENT	H3R47K3TBD	DONNATAL (PHENOBARBITAL ELIXIR) ELIXIR [PBM PHARMACEUTICALS INC.]	4
FD&C Red No. 3	INACTIVE INGREDIENT	PN2ZH5LOQY	DONNATAL (PHENOBARBITAL ELIXIR) ELIXIR [PBM PHARMACEUTICALS INC.]	4
Glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	DONNATAL (PHENOBARBITAL ELIXIR) ELIXIR [PBM PHARMACEUTICALS INC.]	4
MINT	INACTIVE INGREDIENT	FV98Z8GITP	DONNATAL (PHENOBARBITAL ELIXIR) ELIXIR [PBM PHARMACEUTICALS INC.]	4
saccharin sodium	INACTIVE INGREDIENT	SB8ZUX40TY	DONNATAL (PHENOBARBITAL ELIXIR) ELIXIR [PBM PHARMACEUTICALS INC.]	4
sorbitol	INACTIVE INGREDIENT	506T60A25R	DONNATAL (PHENOBARBITAL ELIXIR) ELIXIR [PBM PHARMACEUTICALS INC.]	4
sucrose	INACTIVE INGREDIENT	C151H8M554	DONNATAL (PHENOBARBITAL ELIXIR) ELIXIR [PBM PHARMACEUTICALS INC.]	4
water	INACTIVE INGREDIENT	059QF0KO0R	DONNATAL (PHENOBARBITAL ELIXIR) ELIXIR [PBM PHARMACEUTICALS INC.]	4
Atropine sulfate	ACTIVE INGREDIENT	03J5ZE7KA5	DONNATAL (PHENOBARBITAL ELIXIR) ELIXIR [PBM PHARMACEUTICALS INC.]	3
Hyoscyamine sulfate	ACTIVE INGREDIENT	F2R8V82B84	DONNATAL (PHENOBARBITAL ELIXIR) ELIXIR [PBM PHARMACEUTICALS INC.]	3
Phenobarbital	ACTIVE INGREDIENT	YQE403BP4D	DONNATAL (PHENOBARBITAL ELIXIR) ELIXIR [PBM PHARMACEUTICALS INC.]	3
Scopolamine hydrobromide	ACTIVE INGREDIENT	451IFR0GXB	DONNATAL (PHENOBARBITAL ELIXIR) ELIXIR [PBM PHARMACEUTICALS INC.]	3
Atropine	ACTIVE MOIETY	7C0697DR9I	DONNATAL (PHENOBARBITAL ELIXIR) ELIXIR [PBM PHARMACEUTICALS INC.]	3
Hyoscyamine	ACTIVE MOIETY	PX44XO846X	DONNATAL (PHENOBARBITAL ELIXIR) ELIXIR [PBM PHARMACEUTICALS INC.]	3
Phenobarbital	ACTIVE MOIETY	YQE403BP4D	DONNATAL (PHENOBARBITAL ELIXIR) ELIXIR [PBM PHARMACEUTICALS INC.]	3
Scopolamine	ACTIVE MOIETY	DL48G20X8X	DONNATAL (PHENOBARBITAL ELIXIR) ELIXIR [PBM PHARMACEUTICALS INC.]	3
alcohol	INACTIVE INGREDIENT	3K9958V90M	DONNATAL (PHENOBARBITAL ELIXIR) ELIXIR [PBM PHARMACEUTICALS INC.]	3
FD&C Blue No. 1	INACTIVE INGREDIENT	H3R47K3TBD	DONNATAL (PHENOBARBITAL ELIXIR) ELIXIR [PBM PHARMACEUTICALS INC.]	3
FD&C Red No. 3	INACTIVE INGREDIENT	PN2ZH5LOQY	DONNATAL (PHENOBARBITAL ELIXIR) ELIXIR [PBM PHARMACEUTICALS INC.]	3
Glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	DONNATAL (PHENOBARBITAL ELIXIR) ELIXIR [PBM PHARMACEUTICALS INC.]	3
MINT	INACTIVE INGREDIENT	FV98Z8GITP	DONNATAL (PHENOBARBITAL ELIXIR) ELIXIR [PBM PHARMACEUTICALS INC.]	3
saccharin sodium	INACTIVE INGREDIENT	SB8ZUX40TY	DONNATAL (PHENOBARBITAL ELIXIR) ELIXIR [PBM PHARMACEUTICALS INC.]	3
sorbitol	INACTIVE INGREDIENT	506T60A25R	DONNATAL (PHENOBARBITAL ELIXIR) ELIXIR [PBM PHARMACEUTICALS INC.]	3
sucrose	INACTIVE INGREDIENT	C151H8M554	DONNATAL (PHENOBARBITAL ELIXIR) ELIXIR [PBM PHARMACEUTICALS INC.]	3
water	INACTIVE INGREDIENT	059QF0KO0R	DONNATAL (PHENOBARBITAL ELIXIR) ELIXIR [PBM PHARMACEUTICALS INC.]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
66213-422	DONNATAL (PHENOBARBITAL ELIXIR) ELIXIR [PBM PHARMACEUTICALS INC.]	4	Legacy NDC, 1 package rows	20131204_8d395651-e406-4448-98a7-fc6afc61282d.zip
66213-422	DONNATAL (PHENOBARBITAL ELIXIR) ELIXIR [PBM PHARMACEUTICALS INC.]	3	Legacy NDC, 1 package rows	20131204_ae03915e-8eca-4dab-94ac-00a4571b699b.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
YQE403BP4D	PHENOBARBITAL	50-06-6	PHENOBARBITAL
F2R8V82B84	HYOSCYAMINE SULFATE	6835-16-1	HYOSCYAMINE SULFATE
451IFR0GXB	SCOPOLAMINE HYDROBROMIDE	6533-68-2	SCOPOLAMINE HYDROBROMIDE
03J5ZE7KA5	ATROPINE SULFATE	5908-99-6	ATROPINE SULFATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1046924	Donnatal 16.2 MG / 0.1037 MG / 0.0194 MG / 0.0065 MG in 5 mL Oral Solution	PSN	8d395651-e406-4448-98a7-fc6afc61282d	4
1046787	PHENobarbital 16.2 MG / hyoscyamine sulfate 0.1037 MG / atropine sulfate 0.0194 MG / scopolamine HBr 0.0065 MG in 5 mL Oral Solution	PSN	8d395651-e406-4448-98a7-fc6afc61282d	4
1046924	atropine sulfate 0.00388 MG/ML / hyoscyamine sulfate 0.0207 MG/ML / phenobarbital 3.24 MG/ML / scopolamine hydrobromide 0.0013 MG/ML Oral Solution [Donnatal]	SBD	8d395651-e406-4448-98a7-fc6afc61282d	4
1046787	atropine sulfate 0.00388 MG/ML / hyoscyamine sulfate 0.0207 MG/ML / phenobarbital 3.24 MG/ML / scopolamine hydrobromide 0.0013 MG/ML Oral Solution	SCD	8d395651-e406-4448-98a7-fc6afc61282d	4
1046787	atropine sulfate 0.0194 MG / hyoscyamine sulfate 0.1037 MG / phenobarbital 16.2 MG / scopolamine hydrobromide 0.0065 MG per 5 ML Oral Solution	SY	8d395651-e406-4448-98a7-fc6afc61282d	4
1046924	Donnatal (atropine sulfate 0.00388 MG / hyoscyamine sulfate 0.0207 MG / phenobarbital 3.24 MG / scopolamine hydrobromide 0.0013 MG) per ML Oral Solution	SY	8d395651-e406-4448-98a7-fc6afc61282d	4
1046924	Donnatal (atropine sulfate 0.0194 MG / hyoscyamine sulfate 0.1037 MG / phenobarbital 16.2 MG / scopolamine hydrobromide 0.0065 MG) per 5 ML Oral Solution	SY	8d395651-e406-4448-98a7-fc6afc61282d	4
1046924	Donnatal (atropine sulfate 0.0388 MG / hyoscyamine sulfate 0.2074 MG / phenobarbital 32.4 MG / scopolamine hydrobromide 0.013 MG) per 10 ML Oral Solution	SY	8d395651-e406-4448-98a7-fc6afc61282d	4
1046924	Donnatal 16.2 MG / 0.1037 MG / 0.0194 MG / 0.0065 MG in 5 mL Oral Solution	PSN	ae03915e-8eca-4dab-94ac-00a4571b699b	3
1046787	PHENobarbital 16.2 MG / hyoscyamine sulfate 0.1037 MG / atropine sulfate 0.0194 MG / scopolamine HBr 0.0065 MG in 5 mL Oral Solution	PSN	ae03915e-8eca-4dab-94ac-00a4571b699b	3
1046924	atropine sulfate 0.00388 MG/ML / hyoscyamine sulfate 0.0207 MG/ML / phenobarbital 3.24 MG/ML / scopolamine hydrobromide 0.0013 MG/ML Oral Solution [Donnatal]	SBD	ae03915e-8eca-4dab-94ac-00a4571b699b	3
1046787	atropine sulfate 0.00388 MG/ML / hyoscyamine sulfate 0.0207 MG/ML / phenobarbital 3.24 MG/ML / scopolamine hydrobromide 0.0013 MG/ML Oral Solution	SCD	ae03915e-8eca-4dab-94ac-00a4571b699b	3
1046787	atropine sulfate 0.0194 MG / hyoscyamine sulfate 0.1037 MG / phenobarbital 16.2 MG / scopolamine hydrobromide 0.0065 MG per 5 ML Oral Solution	SY	ae03915e-8eca-4dab-94ac-00a4571b699b	3
1046924	Donnatal (atropine sulfate 0.00388 MG / hyoscyamine sulfate 0.0207 MG / phenobarbital 3.24 MG / scopolamine hydrobromide 0.0013 MG) per ML Oral Solution	SY	ae03915e-8eca-4dab-94ac-00a4571b699b	3
1046924	Donnatal (atropine sulfate 0.0194 MG / hyoscyamine sulfate 0.1037 MG / phenobarbital 16.2 MG / scopolamine hydrobromide 0.0065 MG) per 5 ML Oral Solution	SY	ae03915e-8eca-4dab-94ac-00a4571b699b	3
1046924	Donnatal (atropine sulfate 0.0388 MG / hyoscyamine sulfate 0.2074 MG / phenobarbital 32.4 MG / scopolamine hydrobromide 0.013 MG) per 10 ML Oral Solution	SY	ae03915e-8eca-4dab-94ac-00a4571b699b	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
66213-422-04	66213042204	118 mL in 1 BOTTLE	118 ml	Historical
66213-422-16	66213042216	470 mL in 1 BOTTLE	470 ml	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Donnatal Elixir Mint 16 oz	PBM Pharmaceuticals Inc. \| IriSys, Inc.	2013-12-03	HUMAN PRESCRIPTION DRUG LABEL	4
Donnatal Elixir Mint 4 oz	PBM Pharmaceuticals Inc. \| IriSys, Inc.	2013-12-03	HUMAN PRESCRIPTION DRUG LABEL	3