DICLEGIS

Product NDC: 55494-100
11-digit product format: 554940100
Labeler code: 55494
Product ID: 55494-100_19a108be-4aba-4906-8a5d-35f5b263b1c2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: doxylamine succinate and pyridoxine hydrochloride
Dosage form: TABLET, DELAYED RELEASE
Route: ORAL
Labeler: Duchesnay USA, Inc.
Application: NDA021876
Marketing category: NDA
Marketing start: 2013-05-15
Substance: DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE
Active strength: 10; 10 mg/1; mg/1
Pharmacologic classes: Analogs/Derivatives [Chemical/Ingredient], Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021876-001	DICLEGIS	DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-04-08

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
N021876-001	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N021876-001	DICLEGIS	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-04-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021876-001	DICLEGIS	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-04-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021876-001	DICLEGIS	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-04-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021876-001	DICLEGIS	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-04-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021876-001	DICLEGIS	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-04-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021876-001	DICLEGIS	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-04-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021876-001	DICLEGIS	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-04-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021876-001	DICLEGIS	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-04-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021876-001	DICLEGIS	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-04-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021876-001	DICLEGIS	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-04-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021876-001	DICLEGIS	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-04-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021876-001	DICLEGIS	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-04-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021876-001	DICLEGIS	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-04-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021876-001	DICLEGIS	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-04-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021876-001	DICLEGIS	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-04-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021876-001	DICLEGIS	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-04-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021876-001	DICLEGIS	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-04-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021876-001	DICLEGIS	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-04-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021876-001	DICLEGIS	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-04-08	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021876-001	DICLEGIS	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-04-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021876-001	DICLEGIS	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-04-08	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021876-001	DICLEGIS	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-04-08	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021876-001	DICLEGIS	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-04-08	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021876-001	DICLEGIS	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-04-08	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021876-001	DICLEGIS	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-04-08	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021876-001	DICLEGIS	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-04-08	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021876-001	DICLEGIS	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-04-08	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021876-001	DICLEGIS	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-04-08	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021876-001	DICLEGIS	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-04-08	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021876-001	DICLEGIS	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-04-08	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021876-001	DICLEGIS	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-04-08	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021876-001	DICLEGIS	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-04-08	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021876-001	DICLEGIS	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-04-08	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021876-001	DICLEGIS	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-04-08	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021876-001	DICLEGIS	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-04-08	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021876-001	DICLEGIS	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-04-08	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021876-001	DICLEGIS	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-04-08	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021876-001	DICLEGIS	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-04-08	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021876-001	DICLEGIS	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-04-08	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021876-001	DICLEGIS	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2013-04-08	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N021876-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021876-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021876-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021876-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021876-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021876-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021876-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021876-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021876-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021876-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021876-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021876-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021876-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021876-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021876-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021876-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021876-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021876-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021876-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021876-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021876-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021876-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021876-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021876-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021876-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021876-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021876-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021876-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021876-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021876-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021876-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021876-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021876-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021876-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021876-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021876-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021876-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021876-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021876-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021876-001	AB	1	`e64feba35796…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021876-001	7560122	2019-01-25		Drug product	2013-04-16	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021876-001	6340695	2021-06-21	U-1382	Drug product	2013-04-16	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	N021876-001	6340695	2021-06-21	U-1382	Drug product	2013-04-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021876-001	6340695	2021-06-21	U-1382	Drug product	2013-04-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021876-001	6340695	2021-06-21	U-1382	Drug product	2013-04-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021876-001	6340695	2021-06-21	U-1382	Drug product	2013-04-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021876-001	6340695	2021-06-21	U-1382	Drug product	2013-04-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021876-001	7560122	2019-01-25		Drug product	2013-04-16	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021876-001	6340695	2021-06-21	U-1382	Drug product	2013-04-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021876-001	7560122	2019-01-25		Drug product	2013-04-16	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021876-001	6340695	2021-06-21	U-1382	Drug product	2013-04-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021876-001	7560122	2019-01-25		Drug product	2013-04-16	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021876-001	6340695	2021-06-21	U-1382	Drug product	2013-04-16	`ea99ee380514…`

Additional Listing Data#

Finished product: Yes
Brand name base: DICLEGIS
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DOXYLAMINE SUCCINATE	10 mg/1
PYRIDOXINE HYDROCHLORIDE	10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
V9BI9B5YI2	Internal UNII lookup
68Y4CF58BV	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1375948	Internal RxNorm lookup
1375954	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
8bde08f6-e8bd-4e90-baa7-82e01876a86a	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
59361619-24d9-b610-eca6-5a7f25ed5e03	Product name	5	20240909
fb7ab793-2c12-4079-b100-a64f73bef25a	Product name	4	20240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7	Product name	2	20230717
dc7c5daa-021f-40dd-b00d-63982cb2067a	Product name	1	20230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	5	20200925
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
f4368033-af8c-41bf-a84b-ff77392b8522	Product name	1	20161229
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	2	20160823
5e18e798-5614-cf5c-0185-38b1cb77a093	Product name	2	20160822
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
55494-100-10	2020-07-22	C162847	48780-1	ab0e2407-319f-f274-e053-dbdaa90a6471	These highlights do not include all the information needed to use DICLEGIS safely and effectively. See full prescribing information for DICLEGIS. DICLEGIS (doxylamine succinate and pyridoxine hydrochloride) delayed-release tablets, for oral use. Initial U.S. Approval: 1976
55494-100-99	2020-07-22	C162847	48780-1	ab0e2407-319f-f274-e053-dbdaa90a6471	These highlights do not include all the information needed to use DICLEGIS safely and effectively. See full prescribing information for DICLEGIS. DICLEGIS (doxylamine succinate and pyridoxine hydrochloride) delayed-release tablets, for oral use. Initial U.S. Approval: 1976

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
55494-100-10	DICLEGIS	100 in 1 BOTTLE	TABLET, DELAYED RELEASE	100		15
55494-100-99	DICLEGIS	12 in 1 BOTTLE	TABLET, DELAYED RELEASE	12		15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
55494-100-10	EA - Each	55494-100	6ba7f724-b251-4c6c-9e54-62f4485c8b2d	1	2013-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DOXYLAMINE SUCCINATE	ACTIVE INGREDIENT	V9BI9B5YI2	DICLEGIS (DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE) TABLET, DELAYED RELEASE [DUCHESNAY USA, INC.]	5
PYRIDOXINE HYDROCHLORIDE	ACTIVE INGREDIENT	68Y4CF58BV	DICLEGIS (DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE) TABLET, DELAYED RELEASE [DUCHESNAY USA, INC.]	5
DOXYLAMINE	ACTIVE MOIETY	95QB77JKPL	DICLEGIS (DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE) TABLET, DELAYED RELEASE [DUCHESNAY USA, INC.]	5
PYRIDOXINE	ACTIVE MOIETY	KV2JZ1BI6Z	DICLEGIS (DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE) TABLET, DELAYED RELEASE [DUCHESNAY USA, INC.]	5
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	DICLEGIS (DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE) TABLET, DELAYED RELEASE [DUCHESNAY USA, INC.]	5
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	DICLEGIS (DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE) TABLET, DELAYED RELEASE [DUCHESNAY USA, INC.]	5
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	DICLEGIS (DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE) TABLET, DELAYED RELEASE [DUCHESNAY USA, INC.]	5
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	DICLEGIS (DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE) TABLET, DELAYED RELEASE [DUCHESNAY USA, INC.]	5
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	DICLEGIS (DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE) TABLET, DELAYED RELEASE [DUCHESNAY USA, INC.]	5
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	DICLEGIS (DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE) TABLET, DELAYED RELEASE [DUCHESNAY USA, INC.]	5
D&C RED NO. 27	INACTIVE INGREDIENT	2LRS185U6K	DICLEGIS (DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE) TABLET, DELAYED RELEASE [DUCHESNAY USA, INC.]	5
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	DICLEGIS (DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE) TABLET, DELAYED RELEASE [DUCHESNAY USA, INC.]	5
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	DICLEGIS (DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE) TABLET, DELAYED RELEASE [DUCHESNAY USA, INC.]	5
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	DICLEGIS (DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE) TABLET, DELAYED RELEASE [DUCHESNAY USA, INC.]	5
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	DICLEGIS (DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE) TABLET, DELAYED RELEASE [DUCHESNAY USA, INC.]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DICLEGIS (DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE) TABLET, DELAYED RELEASE [DUCHESNAY USA, INC.]	5
MAGNESIUM TRISILICATE	INACTIVE INGREDIENT	C2E1CI501T	DICLEGIS (DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE) TABLET, DELAYED RELEASE [DUCHESNAY USA, INC.]	5
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	INACTIVE INGREDIENT	NX76LV5T8J	DICLEGIS (DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE) TABLET, DELAYED RELEASE [DUCHESNAY USA, INC.]	5
POLYETHYLENE GLYCOL 8000	INACTIVE INGREDIENT	Q662QK8M3B	DICLEGIS (DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE) TABLET, DELAYED RELEASE [DUCHESNAY USA, INC.]	5
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	DICLEGIS (DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE) TABLET, DELAYED RELEASE [DUCHESNAY USA, INC.]	5
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	DICLEGIS (DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE) TABLET, DELAYED RELEASE [DUCHESNAY USA, INC.]	5
SHELLAC	INACTIVE INGREDIENT	46N107B71O	DICLEGIS (DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE) TABLET, DELAYED RELEASE [DUCHESNAY USA, INC.]	5
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	DICLEGIS (DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE) TABLET, DELAYED RELEASE [DUCHESNAY USA, INC.]	5
SODIUM BICARBONATE	INACTIVE INGREDIENT	8MDF5V39QO	DICLEGIS (DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE) TABLET, DELAYED RELEASE [DUCHESNAY USA, INC.]	5
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	DICLEGIS (DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE) TABLET, DELAYED RELEASE [DUCHESNAY USA, INC.]	5
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	DICLEGIS (DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE) TABLET, DELAYED RELEASE [DUCHESNAY USA, INC.]	5
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	DICLEGIS (DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE) TABLET, DELAYED RELEASE [DUCHESNAY USA, INC.]	5
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	DICLEGIS (DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE) TABLET, DELAYED RELEASE [DUCHESNAY USA, INC.]	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55494-100	DICLEGIS (DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE) TABLET, DELAYED RELEASE [DUCHESNAY USA, INC.]	14	Current NDC, Legacy NDC, 2 package rows	20241219_8bde08f6-e8bd-4e90-baa7-82e01876a86a.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DICLEGIS	DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE	Duchesnay USA, Inc.	8bde08f6-e8bd-4e90-baa7-82e01876a86a	2025-12-03	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021876 application number: NDA021876 ndc (product): 55494-100
Doxylamine succinate and pyridoxine hydrochloride	DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE	Analog Pharma	76d10d65-0279-4e86-8104-cade4343f839	2025-12-03	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021876 application number: NDA021876

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
V9BI9B5YI2	DOXYLAMINE SUCCINATE	562-10-7	DOXYLAMINE SUCCINATE
68Y4CF58BV	PYRIDOXINE HYDROCHLORIDE	58-56-0	PYRIDOXINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1375954	Diclegis 10 MG / 10 MG Delayed Release Oral Tablet	PSN	8bde08f6-e8bd-4e90-baa7-82e01876a86a	15
1375948	doxylamine succinate 10 MG / pyridoxine HCl 10 MG Delayed Release Oral Tablet	PSN	8bde08f6-e8bd-4e90-baa7-82e01876a86a	15
1375954	doxylamine succinate 10 MG / pyridoxine hydrochloride 10 MG Delayed Release Oral Tablet [Diclegis]	SBD	8bde08f6-e8bd-4e90-baa7-82e01876a86a	15
1375948	doxylamine succinate 10 MG / pyridoxine hydrochloride 10 MG Delayed Release Oral Tablet	SCD	8bde08f6-e8bd-4e90-baa7-82e01876a86a	15
1375954	Diclegis (doxylamine succinate 10 MG / pyridoxine hydrochloride 10 MG) Delayed Release Oral Tablet	SY	8bde08f6-e8bd-4e90-baa7-82e01876a86a	15
1375948	doxylamine succinate 10 MG / vit-B6 Hydrochloride 10 MG Delayed Release Oral Tablet	SY	8bde08f6-e8bd-4e90-baa7-82e01876a86a	15
1375954	doxylamine succinate 10 MG / vit-B6 Hydrochloride 10 MG Delayed Release Oral Tablet [Diclegis]	SY	8bde08f6-e8bd-4e90-baa7-82e01876a86a	15
1375948	doxylamine succinate 10 MG / vitamin B6 Hydrochloride 10 MG Delayed Release Oral Tablet	SY	8bde08f6-e8bd-4e90-baa7-82e01876a86a	15
1375954	doxylamine succinate 10 MG / vitamin B6 Hydrochloride 10 MG Delayed Release Oral Tablet [Diclegis]	SY	8bde08f6-e8bd-4e90-baa7-82e01876a86a	15

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
55494-100-10	55494010010	100 TABLET, DELAYED RELEASE in 1 BOTTLE (55494-100-10)	2013-05-15	0000-00-00	No	No	Current
55494-100-99	55494010099	12 TABLET, DELAYED RELEASE in 1 BOTTLE (55494-100-99)	2014-03-28	0000-00-00	Yes	No	Current