PRED MILD

Product NDC: 11980-174
11-digit product format: 119800174
Labeler code: 11980
Product ID: 11980-174_02594e74-d6cf-40b5-bfb1-c27be33e0e35
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: prednisolone acetate
Dosage form: SUSPENSION/ DROPS
Route: OPHTHALMIC
Labeler: Allergan, Inc.
Application: NDA017100
Marketing category: NDA
Marketing start: 1972-12-01
Substance: PREDNISOLONE ACETATE
Active strength: 1.2 mg/mL
Pharmacologic classes: Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N017100-001	PRED MILD	PREDNISOLONE ACETATE	0.12%	SUSPENSION/DROPS / OPHTHALMIC		RLD, RS, Approved before 1982

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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N017100-001	PRED MILD	0.12%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017100-001	PRED MILD	0.12%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N017100-001	PRED MILD	0.12%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017100-001	PRED MILD	0.12%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017100-001	PRED MILD	0.12%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017100-001	PRED MILD	0.12%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017100-001	PRED MILD	0.12%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017100-001	PRED MILD	0.12%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017100-001	PRED MILD	0.12%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N017100-001	PRED MILD	0.12%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017100-001	PRED MILD	0.12%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017100-001	PRED MILD	0.12%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017100-001	PRED MILD	0.12%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N017100-001	PRED MILD	0.12%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N017100-001	PRED MILD	0.12%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N017100-001	PRED MILD	0.12%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N017100-001	PRED MILD	0.12%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N017100-001	PRED MILD	0.12%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N017100-001	PRED MILD	0.12%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N017100-001	PRED MILD	0.12%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N017100-001	PRED MILD	0.12%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N017100-001	PRED MILD	0.12%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N017100-001	PRED MILD	0.12%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N017100-001	PRED MILD	0.12%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N017100-001	PRED MILD	0.12%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N017100-001	PRED MILD	0.12%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N017100-001	PRED MILD	0.12%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N017100-001	PRED MILD	0.12%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N017100-001	PRED MILD	0.12%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N017100-001	PRED MILD	0.12%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N017100-001	PRED MILD	0.12%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N017100-001	PRED MILD	0.12%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N017100-001	PRED MILD	0.12%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N017100-001	PRED MILD	0.12%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N017100-001	PRED MILD	0.12%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N017100-001	PRED MILD	0.12%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N017100-001	PRED MILD	0.12%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N017100-001	PRED MILD	0.12%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N017100-001	PRED MILD	0.12%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS, Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N017100-001	PRED MILD	0.12%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS, Approved before 1982	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: PRED MILD
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PREDNISOLONE ACETATE	1.2 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
8B2807733D	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
209002	Internal RxNorm lookup
562379	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
4fcce64a-94ea-4031-ad5a-c4eddc73a910	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
b3fecff3-fb51-4f66-b443-a130905bb500	Product name	1	20250804
3a7a0034-a88d-88c3-f43e-ea34c6a216de	Product name	2	20250311
9dbc4744-f7be-4393-b71a-e1bfd8b97659	Product name	2	20250218
9e44d9f9-cb87-3b0f-4c71-c8438d0dc2e5	Product name	2	20240102
a0e37fa3-7f16-4fbf-bdb7-ae82cb1a553a	Product name	1	20170309
af7d3306-1338-423f-839e-419aad9e8a86	Product name	1	20170309
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
18d57d04-4a34-a130-5dd5-b7fc47f3b567	Product name	1	20140508
379bc253-901a-e6e1-92b7-0fc574249e07	Product name	1	20140508
48b05f5d-d2fc-45ab-76e8-3cb5bd44890d	Product name	1	20140508
73adedd8-aba8-27d9-78d9-2e3c4a3cf954	Product name	1	20140508
9ae74339-0a3d-82e9-5dd1-88bd2607bd6b	Product name	1	20140508
9f10552a-9a7b-8e6c-3223-dc44310af6cf	Product name	1	20140508
e44e38a9-2d9e-b0e2-cce9-490554639f3d	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
11980-174-05	PRED MILD	5 mL in 1 BOTTLE, DROPPER	SUSPENSION/ DROPS	5	16
11980-174-05	PRED MILD	1 in 1 CARTON	SUSPENSION/ DROPS	1	16
11980-174-10	PRED MILD	1 in 1 CARTON	SUSPENSION/ DROPS	1	16
11980-174-10	PRED MILD	10 mL in 1 BOTTLE, DROPPER	SUSPENSION/ DROPS	10	16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
11980-174-05	ML - Milliliter	11980-174	424bea18-66e6-468a-9177-543c5bb6df91	1	2012-07-24
11980-174-10	ML - Milliliter	11980-174	f8179da6-de60-4166-962d-99032510e7e3	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
prednisolone acetate	ACTIVE INGREDIENT	8B2807733D	PRED MILD (PREDNISOLONE ACETATE) SUSPENSION/ DROPS [ALLERGAN, INC.]	4
prednisolone	ACTIVE MOIETY	9PHQ9Y1OLM	PRED MILD (PREDNISOLONE ACETATE) SUSPENSION/ DROPS [ALLERGAN, INC.]	4
benzalkonium chloride	INACTIVE INGREDIENT	F5UM2KM3W7	PRED MILD (PREDNISOLONE ACETATE) SUSPENSION/ DROPS [ALLERGAN, INC.]	4
boric acid	INACTIVE INGREDIENT	R57ZHV85D4	PRED MILD (PREDNISOLONE ACETATE) SUSPENSION/ DROPS [ALLERGAN, INC.]	4
edetate disodium	INACTIVE INGREDIENT	7FLD91C86K	PRED MILD (PREDNISOLONE ACETATE) SUSPENSION/ DROPS [ALLERGAN, INC.]	4
hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	PRED MILD (PREDNISOLONE ACETATE) SUSPENSION/ DROPS [ALLERGAN, INC.]	4
polysorbate 80	INACTIVE INGREDIENT	6OZP39ZG8H	PRED MILD (PREDNISOLONE ACETATE) SUSPENSION/ DROPS [ALLERGAN, INC.]	4
sodium bisulfite	INACTIVE INGREDIENT	TZX5469Z6I	PRED MILD (PREDNISOLONE ACETATE) SUSPENSION/ DROPS [ALLERGAN, INC.]	4
sodium chloride	INACTIVE INGREDIENT	451W47IQ8X	PRED MILD (PREDNISOLONE ACETATE) SUSPENSION/ DROPS [ALLERGAN, INC.]	4
sodium citrate	INACTIVE INGREDIENT	1Q73Q2JULR	PRED MILD (PREDNISOLONE ACETATE) SUSPENSION/ DROPS [ALLERGAN, INC.]	4
water	INACTIVE INGREDIENT	059QF0KO0R	PRED MILD (PREDNISOLONE ACETATE) SUSPENSION/ DROPS [ALLERGAN, INC.]	4
prednisolone acetate	ACTIVE INGREDIENT	8B2807733D	PRED MILD (PREDNISOLONE ACETATE) SUSPENSION/ DROPS [PHYSICIANS TOTAL CARE, INC.]	1
prednisolone	ACTIVE MOIETY	9PHQ9Y1OLM	PRED MILD (PREDNISOLONE ACETATE) SUSPENSION/ DROPS [PHYSICIANS TOTAL CARE, INC.]	1
benzalkonium chloride	INACTIVE INGREDIENT	F5UM2KM3W7	PRED MILD (PREDNISOLONE ACETATE) SUSPENSION/ DROPS [PHYSICIANS TOTAL CARE, INC.]	1
boric acid	INACTIVE INGREDIENT	R57ZHV85D4	PRED MILD (PREDNISOLONE ACETATE) SUSPENSION/ DROPS [PHYSICIANS TOTAL CARE, INC.]	1
edetate disodium	INACTIVE INGREDIENT	7FLD91C86K	PRED MILD (PREDNISOLONE ACETATE) SUSPENSION/ DROPS [PHYSICIANS TOTAL CARE, INC.]	1
hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	PRED MILD (PREDNISOLONE ACETATE) SUSPENSION/ DROPS [PHYSICIANS TOTAL CARE, INC.]	1
polysorbate 80	INACTIVE INGREDIENT	6OZP39ZG8H	PRED MILD (PREDNISOLONE ACETATE) SUSPENSION/ DROPS [PHYSICIANS TOTAL CARE, INC.]	1
sodium bisulfite	INACTIVE INGREDIENT	TZX5469Z6I	PRED MILD (PREDNISOLONE ACETATE) SUSPENSION/ DROPS [PHYSICIANS TOTAL CARE, INC.]	1
sodium chloride	INACTIVE INGREDIENT	451W47IQ8X	PRED MILD (PREDNISOLONE ACETATE) SUSPENSION/ DROPS [PHYSICIANS TOTAL CARE, INC.]	1
sodium citrate	INACTIVE INGREDIENT	1Q73Q2JULR	PRED MILD (PREDNISOLONE ACETATE) SUSPENSION/ DROPS [PHYSICIANS TOTAL CARE, INC.]	1
water	INACTIVE INGREDIENT	059QF0KO0R	PRED MILD (PREDNISOLONE ACETATE) SUSPENSION/ DROPS [PHYSICIANS TOTAL CARE, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
11980-174	PRED MILD (PREDNISOLONE ACETATE) SUSPENSION/ DROPS [ALLERGAN, INC.]	13	Current NDC, Legacy NDC, 4 package rows	20240306_4fcce64a-94ea-4031-ad5a-c4eddc73a910.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
PRED MILD	PREDNISOLONE ACETATE	Allergan, Inc.	4fcce64a-94ea-4031-ad5a-c4eddc73a910	2025-11-25	Warnings, Adverse reactions	Exact identifier application applno (NDA): 017100 application number: NDA017100 ndc (product): 11980-174

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
8B2807733D	PREDNISOLONE ACETATE	52-21-1	PREDNISOLONE ACETATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
209002	PRED MILD 0.12 % Ophthalmic Suspension	PSN	4fcce64a-94ea-4031-ad5a-c4eddc73a910	16
562379	prednisoLONE acetate 0.12 % Ophthalmic Suspension	PSN	4fcce64a-94ea-4031-ad5a-c4eddc73a910	16
209002	prednisolone 1.2 MG/ML Ophthalmic Suspension [Pred Mild]	SBD	4fcce64a-94ea-4031-ad5a-c4eddc73a910	16
562379	prednisolone 1.2 MG/ML Ophthalmic Suspension	SCD	4fcce64a-94ea-4031-ad5a-c4eddc73a910	16
209002	Pred Mild 0.12 % Ophthalmic Suspension	SY	4fcce64a-94ea-4031-ad5a-c4eddc73a910	16
209002	Pred Mild 1.2 MG/ML Ophthalmic Suspension	SY	4fcce64a-94ea-4031-ad5a-c4eddc73a910	16
562379	prednisolone 0.12 % Ophthalmic Suspension	SY	4fcce64a-94ea-4031-ad5a-c4eddc73a910	16
209002	PRED MILD 0.12 % Ophthalmic Suspension	PSN	4c1ec8d2-9128-402e-a723-87dc7b444655	1
562379	prednisoLONE acetate 0.12 % Ophthalmic Suspension	PSN	4c1ec8d2-9128-402e-a723-87dc7b444655	1
209002	prednisolone 1.2 MG/ML Ophthalmic Suspension [Pred Mild]	SBD	4c1ec8d2-9128-402e-a723-87dc7b444655	1
562379	prednisolone 1.2 MG/ML Ophthalmic Suspension	SCD	4c1ec8d2-9128-402e-a723-87dc7b444655	1
209002	Pred Mild 0.12 % Ophthalmic Suspension	SY	4c1ec8d2-9128-402e-a723-87dc7b444655	1
209002	Pred Mild 1.2 MG/ML Ophthalmic Suspension	SY	4c1ec8d2-9128-402e-a723-87dc7b444655	1
562379	prednisolone 0.12 % Ophthalmic Suspension	SY	4c1ec8d2-9128-402e-a723-87dc7b444655	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
11980-174-05	11980017405	1 BOTTLE, DROPPER in 1 CARTON (11980-174-05) / 5 mL in 1 BOTTLE, DROPPER	1972-12-01	0000-00-00	No	No	Current
11980-174-10	11980017410	1 BOTTLE, DROPPER in 1 CARTON (11980-174-10) / 10 mL in 1 BOTTLE, DROPPER	1972-12-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PRED MILD ® (prednisolone acetate ophthalmic suspension, USP) 0.12% sterile	Allergan, Inc.	2025-11-25	HUMAN PRESCRIPTION DRUG LABEL	16
PRED MILD ® (prednisolone acetate ophthalmic suspension, USP) 0.12%	Physicians Total Care, Inc.	2013-01-02	HUMAN PRESCRIPTION DRUG LABEL	1