Mondoxyne NL 100mg

Manufacturer: Oculus Innovative Sciences
Effective date: 2015-09-11
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 20:21:10

Label at a glance#

ProductMondoxyne NL 100mg

Active ingredientDOXYCYCLINE

Label structure2 sections

Label contents#

Full prescribing information#

Warnings Mondoxyne NL 100mg

WARNINGS SECTION

Keep this and all medications out of the reach of children.

Mondoxyne NL 100mg

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Mondoxyne NL 100mg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1649990	doxycycline monohydrate 100 MG Oral Capsule	PSN	1
1666542	Mondoxyne NL 100 MG Oral Capsule	PSN	1
1666542	doxycycline monohydrate 100 MG Oral Capsule [Mondoxyne]	SBD	1
1649990	doxycycline monohydrate 100 MG Oral Capsule	SCD	1
1666542	Mondoxyne 100 MG Oral Capsule	SY	1

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
DOXYCYCLINE ANHYDROUS Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20181113

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
b4321c75-2e87-4d90-9726-9a28fb2293a3	Product name	3	20260112
5e99724e-0654-4aec-b7a2-0b9b10e312ee	Product name	3	20250227
d2d36660-68ce-7e7d-0630-ec4b0d859fad	Product name	6	20220921
a239f4dd-cf93-4660-b190-f97d000f249f	Product name	7	20210607
a9d03566-caeb-4466-8021-74599b048880	Product name	3	20210604
12750814-20f7-4f35-b5fa-dbc8811ba858	Product name	9	20201007
00a5dbaa-1b7d-4e56-be0c-fedc7bbf5ade	Product name	1	20200706
7b4b06ac-8c50-45f0-9556-293ea558a294	Product name	1	20180808
6a5b4392-5ab0-af0d-e0be-47b34e9dbb84	Product name	5	20171121
01a4aa74-7e05-63bd-bc10-1b5ceb111371	Product name	2	20171115
58b1278c-6dce-49b6-a05e-ea16f389acba	Product name	1	20160620

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
69668-433-01	2020-01-31	C162847	48780-1	9d75b9d0-d0a5-f424-e053-dadaa90a57ce	Monodoxyne NL 100mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69668-433-01	Mondoxyne NL 100mg	100 mg in 1 BOTTLE	CAPSULE	100		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69668-433	MONDOXYNE NL 100MG (DOXYCYCLINE) CAPSULE [OCULUS INNOVATIVE SCIENCES]	1	Legacy NDC, 1 package rows	20150912_1f80aef4-3ca9-42ec-e054-00144ff8d46c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69668-433-01	EA - Each	69668-433	3bb2f051-7570-4633-9de6-b55cc0451987	1	2015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version	Uploaded
DOXYCYCLINE	ACTIVE INGREDIENT	N12000U13O	1
DOXYCYCLINE ANHYDROUS	ACTIVE MOIETY	334895S862	1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 3 matching rows.

Mondoxyne NL 100mg
Doxycycline
DOXYCYCLINE ANHYDROUS

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
69668-433	69668-433-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 1 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
DOXYCYCLINE	N12000U13O	ACTIM

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A204446-001	DOXYCYCLINE	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	2015-05-28
A204446-002	DOXYCYCLINE	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	2015-05-28
A204446-003	DOXYCYCLINE	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	2015-05-28

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 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A204446-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	2015-05-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A204446-002	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	2015-05-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A204446-003	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	2015-05-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A204446-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	2015-05-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204446-002	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	2015-05-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204446-003	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	2015-05-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204446-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	2015-05-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204446-002	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	2015-05-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204446-003	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	2015-05-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204446-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	2015-05-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204446-002	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	2015-05-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204446-003	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	2015-05-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204446-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	2015-05-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204446-002	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	2015-05-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204446-003	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	2015-05-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204446-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	2015-05-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204446-002	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	2015-05-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204446-003	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	2015-05-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204446-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	2015-05-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204446-002	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	2015-05-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204446-003	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	2015-05-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204446-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	2015-05-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204446-002	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	2015-05-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204446-003	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	2015-05-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204446-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	2015-05-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204446-002	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	2015-05-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204446-003	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	2015-05-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204446-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	2015-05-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204446-002	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	2015-05-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204446-003	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	2015-05-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204446-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	2015-05-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204446-002	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	2015-05-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204446-003	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	2015-05-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204446-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	2015-05-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204446-002	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	2015-05-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204446-003	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	2015-05-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204446-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	2015-05-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204446-002	DOXYCYCLINE	EQ 75MG BASE	CAPSULE / ORAL	2015-05-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204446-003	DOXYCYCLINE	EQ 100MG BASE	CAPSULE / ORAL	2015-05-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204446-001	DOXYCYCLINE	EQ 50MG BASE	CAPSULE / ORAL	2015-05-28	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 78 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204446-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204446-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204446-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204446-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204446-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204446-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204446-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204446-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204446-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204446-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204446-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204446-003	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204446-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A204446-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A204446-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204446-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A204446-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A204446-003	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204446-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204446-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204446-003	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204446-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A204446-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A204446-003	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204446-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A204446-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A204446-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204446-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A204446-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A204446-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204446-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A204446-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A204446-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204446-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A204446-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A204446-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204446-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A204446-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A204446-003	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204446-001	AB	1	`6a51e52b5d6a…`

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
1f80aef4-3caa-42ec-e054-00144ff8d46c			1f80aef4-3ca9-42ec-e054-00144ff8d46c	2015-09-11	Warnings	Exact identifier spl id: 1f80aef4-3caa-42ec-e054-00144ff8d46c spl set id: 1f80aef4-3ca9-42ec-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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