FDA.reportPublic FDA data

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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOXYLAMINE SUCCINATE10 mg/1
PYRIDOXINE HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiV9BI9B5YI2, 68Y4CF58BV
Rxcui1375948, 1375954

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
f4368033-af8c-41bf-a84b-ff77392b8522Product name120161229
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55494-100-102020-07-22C16284748780-1ab0e2407-319f-f274-e053-dbdaa90a6471These 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
55494-100-992020-07-22C16284748780-1ab0e2407-319f-f274-e053-dbdaa90a6471These 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 NDCProductDescriptionFormQuantityStrengthSPL version
55494-100-10DICLEGIS100 in 1 BOTTLETABLET, DELAYED RELEASE10015
55494-100-99DICLEGIS12 in 1 BOTTLETABLET, DELAYED RELEASE1215

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55494-100-10EA - Each55494-1006ba7f724-b251-4c6c-9e54-62f4485c8b2d12013-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DOXYLAMINE SUCCINATEACTIVE INGREDIENTV9BI9B5YI2DICLEGIS (DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE) TABLET, DELAYED RELEASE [DUCHESNAY USA, INC.]5
PYRIDOXINE HYDROCHLORIDEACTIVE INGREDIENT68Y4CF58BVDICLEGIS (DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE) TABLET, DELAYED RELEASE [DUCHESNAY USA, INC.]5
DOXYLAMINEACTIVE MOIETY95QB77JKPLDICLEGIS (DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE) TABLET, DELAYED RELEASE [DUCHESNAY USA, INC.]5
PYRIDOXINEACTIVE MOIETYKV2JZ1BI6ZDICLEGIS (DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE) TABLET, DELAYED RELEASE [DUCHESNAY USA, INC.]5
ALCOHOLINACTIVE INGREDIENT3K9958V90MDICLEGIS (DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE) TABLET, DELAYED RELEASE [DUCHESNAY USA, INC.]5
AMMONIAINACTIVE INGREDIENT5138Q19F1XDICLEGIS (DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE) TABLET, DELAYED RELEASE [DUCHESNAY USA, INC.]5
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3DICLEGIS (DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE) TABLET, DELAYED RELEASE [DUCHESNAY USA, INC.]5
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZDICLEGIS (DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE) TABLET, DELAYED RELEASE [DUCHESNAY USA, INC.]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDICLEGIS (DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE) TABLET, DELAYED RELEASE [DUCHESNAY USA, INC.]5
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48DICLEGIS (DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE) TABLET, DELAYED RELEASE [DUCHESNAY USA, INC.]5
D&C RED NO. 27INACTIVE INGREDIENT2LRS185U6KDICLEGIS (DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE) TABLET, DELAYED RELEASE [DUCHESNAY USA, INC.]5
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1ODICLEGIS (DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE) TABLET, DELAYED RELEASE [DUCHESNAY USA, INC.]5
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKDICLEGIS (DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE) TABLET, DELAYED RELEASE [DUCHESNAY USA, INC.]5
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODICLEGIS (DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE) TABLET, DELAYED RELEASE [DUCHESNAY USA, INC.]5
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302DICLEGIS (DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE) TABLET, DELAYED RELEASE [DUCHESNAY USA, INC.]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DICLEGIS (DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE) TABLET, DELAYED RELEASE [DUCHESNAY USA, INC.]5
MAGNESIUM TRISILICATEINACTIVE INGREDIENTC2E1CI501TDICLEGIS (DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE) TABLET, DELAYED RELEASE [DUCHESNAY USA, INC.]5
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JDICLEGIS (DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE) TABLET, DELAYED RELEASE [DUCHESNAY USA, INC.]5
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BDICLEGIS (DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE) TABLET, DELAYED RELEASE [DUCHESNAY USA, INC.]5
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HDICLEGIS (DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE) TABLET, DELAYED RELEASE [DUCHESNAY USA, INC.]5
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DICLEGIS (DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE) TABLET, DELAYED RELEASE [DUCHESNAY USA, INC.]5
SHELLACINACTIVE INGREDIENT46N107B71ODICLEGIS (DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE) TABLET, DELAYED RELEASE [DUCHESNAY USA, INC.]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DICLEGIS (DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE) TABLET, DELAYED RELEASE [DUCHESNAY USA, INC.]5
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QODICLEGIS (DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE) TABLET, DELAYED RELEASE [DUCHESNAY USA, INC.]5
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDICLEGIS (DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE) TABLET, DELAYED RELEASE [DUCHESNAY USA, INC.]5
TALCINACTIVE INGREDIENT7SEV7J4R1UDICLEGIS (DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE) TABLET, DELAYED RELEASE [DUCHESNAY USA, INC.]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDICLEGIS (DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE) TABLET, DELAYED RELEASE [DUCHESNAY USA, INC.]5
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMDICLEGIS (DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE) TABLET, DELAYED RELEASE [DUCHESNAY USA, INC.]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55494-100DICLEGIS (DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE) TABLET, DELAYED RELEASE [DUCHESNAY USA, INC.]14Current NDC, Legacy NDC, 2 package rows20241219_8bde08f6-e8bd-4e90-baa7-82e01876a86a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1375954Diclegis 10 MG / 10 MG Delayed Release Oral TabletPSN8bde08f6-e8bd-4e90-baa7-82e01876a86a15
1375948doxylamine succinate 10 MG / pyridoxine HCl 10 MG Delayed Release Oral TabletPSN8bde08f6-e8bd-4e90-baa7-82e01876a86a15
1375954doxylamine succinate 10 MG / pyridoxine hydrochloride 10 MG Delayed Release Oral Tablet [Diclegis]SBD8bde08f6-e8bd-4e90-baa7-82e01876a86a15
1375948doxylamine succinate 10 MG / pyridoxine hydrochloride 10 MG Delayed Release Oral TabletSCD8bde08f6-e8bd-4e90-baa7-82e01876a86a15
1375954Diclegis (doxylamine succinate 10 MG / pyridoxine hydrochloride 10 MG) Delayed Release Oral TabletSY8bde08f6-e8bd-4e90-baa7-82e01876a86a15
1375948doxylamine succinate 10 MG / vit-B6 Hydrochloride 10 MG Delayed Release Oral TabletSY8bde08f6-e8bd-4e90-baa7-82e01876a86a15
1375954doxylamine succinate 10 MG / vit-B6 Hydrochloride 10 MG Delayed Release Oral Tablet [Diclegis]SY8bde08f6-e8bd-4e90-baa7-82e01876a86a15
1375948doxylamine succinate 10 MG / vitamin B6 Hydrochloride 10 MG Delayed Release Oral TabletSY8bde08f6-e8bd-4e90-baa7-82e01876a86a15
1375954doxylamine succinate 10 MG / vitamin B6 Hydrochloride 10 MG Delayed Release Oral Tablet [Diclegis]SY8bde08f6-e8bd-4e90-baa7-82e01876a86a15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55494-100-1055494010010100 TABLET, DELAYED RELEASE in 1 BOTTLE (55494-100-10) 2013-05-150000-00-00NoNoCurrent
55494-100-995549401009912 TABLET, DELAYED RELEASE in 1 BOTTLE (55494-100-99) 2014-03-280000-00-00YesNoCurrent