Ibuprofen

Product NDC: 45802-952
11-digit product format: 458020952
Labeler code: 45802
Product ID: 45802-952_155cb0b6-81cf-4187-a508-d22b47496707
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ibuprofen
Dosage form: SUSPENSION
Route: ORAL
Labeler: Padagis Israel Pharmaceuticals Ltd
Application: ANDA076925
Marketing category: ANDA
Marketing start: 2004-12-08
Substance: IBUPROFEN
Active strength: 100 mg/5mL
Pharmacologic classes: Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
IBUPROFEN	100 mg/5mL

Harmonized Identifiers#

Field, Values table
Field	Values
Unii	WK2XYI10QM
Rxcui	197803

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
1e73f975-1ce7-705e-2bcf-788b1b5e24ba	Product name	5	20251124
16cde546-8deb-4df2-a072-dab5566ede95	Product name	1	20231003
f6d1b8d7-3bd1-4248-eddd-b60565c88015	Product name	4	20230808
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
874f4e63-49d2-5150-5d77-052172814ebd	Product name	6	20230105
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717
557673c2-8256-b351-e863-4ec71a5a64b0	Product name	2	20160714
dbc9a339-6215-4e94-9546-57a3b34902ce	Product name	1	20160517
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
6084a4f4-5437-c9a5-caec-5361ee075a59	Product name	1	20140508
61c18d4e-b552-5478-8fc0-df38b93e3100	Product name	1	20140508
7b2938c9-7eb7-e312-ae90-f54f4240361e	Product name	1	20140508
90c5639a-61b0-88d6-ddcf-21888e94869a	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
997601aa-bb5f-6971-6b90-a21132c12c7b	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
45802-952-26	Ibuprofen	1 in 1 CARTON	SUSPENSION	1	17
45802-952-26	Ibuprofen	120 mL in 1 BOTTLE	SUSPENSION	120	17
45802-952-43	Ibuprofen	473 mL in 1 BOTTLE	SUSPENSION	473	17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
45802-952-26	ML - Milliliter	45802-952	c468fdc0-442d-4402-90ca-2974cd84af1d	1	2012-07-24
45802-952-43	ML - Milliliter	45802-952	5abed74b-dbc6-400a-9527-518e2a939cb3	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
IBUPROFEN	ACTIVE INGREDIENT	WK2XYI10QM	IBUPROFEN SUSPENSION [PERRIGO NEW YORK INC]	5
IBUPROFEN	ACTIVE MOIETY	WK2XYI10QM	IBUPROFEN SUSPENSION [PERRIGO NEW YORK INC]	5
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	IBUPROFEN SUSPENSION [PERRIGO NEW YORK INC]	5
BUTYLPARABEN	INACTIVE INGREDIENT	3QPI1U3FV8	IBUPROFEN SUSPENSION [PERRIGO NEW YORK INC]	5
D&C RED NO. 33	INACTIVE INGREDIENT	9DBA0SBB0L	IBUPROFEN SUSPENSION [PERRIGO NEW YORK INC]	5
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	IBUPROFEN SUSPENSION [PERRIGO NEW YORK INC]	5
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	IBUPROFEN SUSPENSION [PERRIGO NEW YORK INC]	5
HIGH FRUCTOSE CORN SYRUP	INACTIVE INGREDIENT	XY6UN3QB6S	IBUPROFEN SUSPENSION [PERRIGO NEW YORK INC]	5
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	IBUPROFEN SUSPENSION [PERRIGO NEW YORK INC]	5
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	IBUPROFEN SUSPENSION [PERRIGO NEW YORK INC]	5
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	IBUPROFEN SUSPENSION [PERRIGO NEW YORK INC]	5
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	IBUPROFEN SUSPENSION [PERRIGO NEW YORK INC]	5
SORBITOL	INACTIVE INGREDIENT	506T60A25R	IBUPROFEN SUSPENSION [PERRIGO NEW YORK INC]	5
WATER	INACTIVE INGREDIENT	059QF0KO0R	IBUPROFEN SUSPENSION [PERRIGO NEW YORK INC]	5
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	IBUPROFEN SUSPENSION [PERRIGO NEW YORK INC]	5
IBUPROFEN	ACTIVE INGREDIENT	WK2XYI10QM	IBUPROFEN SUSPENSION [PHYSICIANS TOTAL CARE, INC.]	3
IBUPROFEN	ACTIVE MOIETY	WK2XYI10QM	IBUPROFEN SUSPENSION [PHYSICIANS TOTAL CARE, INC.]	3
BUTYLPARABEN	INACTIVE INGREDIENT	3QPI1U3FV8	IBUPROFEN SUSPENSION [PHYSICIANS TOTAL CARE, INC.]	3
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	IBUPROFEN SUSPENSION [PHYSICIANS TOTAL CARE, INC.]	3
CORN SYRUP	INACTIVE INGREDIENT	9G5L16BK6N	IBUPROFEN SUSPENSION [PHYSICIANS TOTAL CARE, INC.]	3
D&C RED NO. 33	INACTIVE INGREDIENT	9DBA0SBB0L	IBUPROFEN SUSPENSION [PHYSICIANS TOTAL CARE, INC.]	3
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	IBUPROFEN SUSPENSION [PHYSICIANS TOTAL CARE, INC.]	3
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	IBUPROFEN SUSPENSION [PHYSICIANS TOTAL CARE, INC.]	3
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	IBUPROFEN SUSPENSION [PHYSICIANS TOTAL CARE, INC.]	3
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	IBUPROFEN SUSPENSION [PHYSICIANS TOTAL CARE, INC.]	3
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	IBUPROFEN SUSPENSION [PHYSICIANS TOTAL CARE, INC.]	3
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	IBUPROFEN SUSPENSION [PHYSICIANS TOTAL CARE, INC.]	3
SORBITOL	INACTIVE INGREDIENT	506T60A25R	IBUPROFEN SUSPENSION [PHYSICIANS TOTAL CARE, INC.]	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	IBUPROFEN SUSPENSION [PHYSICIANS TOTAL CARE, INC.]	3
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	IBUPROFEN SUSPENSION [PHYSICIANS TOTAL CARE, INC.]	3
Ibuprofen	ACTIVE INGREDIENT	WK2XYI10QM	IBUPROFEN SUSPENSION [REBEL DISTRIBUTORS CORP]	1
IBUPROFEN	ACTIVE INGREDIENT	WK2XYI10QM	IBUPROFEN SUSPENSION [STAT RX USA LLC]	1
Ibuprofen	ACTIVE MOIETY	WK2XYI10QM	IBUPROFEN SUSPENSION [REBEL DISTRIBUTORS CORP]	1
IBUPROFEN	ACTIVE MOIETY	WK2XYI10QM	IBUPROFEN SUSPENSION [STAT RX USA LLC]	1
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	IBUPROFEN SUSPENSION [STAT RX USA LLC]	1
BUTYLPARABEN	INACTIVE INGREDIENT	3QPI1U3FV8	IBUPROFEN SUSPENSION [STAT RX USA LLC]	1
butylparaben	INACTIVE INGREDIENT	3QPI1U3FV8	IBUPROFEN SUSPENSION [REBEL DISTRIBUTORS CORP]	1
citric acid	INACTIVE INGREDIENT	2968PHW8QP	IBUPROFEN SUSPENSION [REBEL DISTRIBUTORS CORP]	1
CORN SYRUP	INACTIVE INGREDIENT	9G5L16BK6N	IBUPROFEN SUSPENSION [REBEL DISTRIBUTORS CORP]	1
D&C RED NO. 33	INACTIVE INGREDIENT	9DBA0SBB0L	IBUPROFEN SUSPENSION [STAT RX USA LLC]	1
D&C RED NO. 33	INACTIVE INGREDIENT	9DBA0SBB0L	IBUPROFEN SUSPENSION [REBEL DISTRIBUTORS CORP]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	IBUPROFEN SUSPENSION [REBEL DISTRIBUTORS CORP]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	IBUPROFEN SUSPENSION [STAT RX USA LLC]	1
glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	IBUPROFEN SUSPENSION [REBEL DISTRIBUTORS CORP]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	IBUPROFEN SUSPENSION [STAT RX USA LLC]	1
HIGH FRUCTOSE CORN SYRUP	INACTIVE INGREDIENT	XY6UN3QB6S	IBUPROFEN SUSPENSION [STAT RX USA LLC]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	IBUPROFEN SUSPENSION [REBEL DISTRIBUTORS CORP]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	IBUPROFEN SUSPENSION [STAT RX USA LLC]	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	IBUPROFEN SUSPENSION [REBEL DISTRIBUTORS CORP]	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	IBUPROFEN SUSPENSION [STAT RX USA LLC]	1
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	IBUPROFEN SUSPENSION [REBEL DISTRIBUTORS CORP]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	IBUPROFEN SUSPENSION [STAT RX USA LLC]	1
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	IBUPROFEN SUSPENSION [STAT RX USA LLC]	1
sodium benzoate	INACTIVE INGREDIENT	OJ245FE5EU	IBUPROFEN SUSPENSION [REBEL DISTRIBUTORS CORP]	1
SORBITOL	INACTIVE INGREDIENT	506T60A25R	IBUPROFEN SUSPENSION [STAT RX USA LLC]	1
sorbitol	INACTIVE INGREDIENT	506T60A25R	IBUPROFEN SUSPENSION [REBEL DISTRIBUTORS CORP]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	IBUPROFEN SUSPENSION [STAT RX USA LLC]	1
water	INACTIVE INGREDIENT	059QF0KO0R	IBUPROFEN SUSPENSION [REBEL DISTRIBUTORS CORP]	1
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	IBUPROFEN SUSPENSION [STAT RX USA LLC]	1
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	IBUPROFEN SUSPENSION [REBEL DISTRIBUTORS CORP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
45802-952	IBUPROFEN SUSPENSION [PADAGIS ISRAEL PHARMACEUTICALS LTD]	15	Current NDC, Legacy NDC, 3 package rows	20240810_998f2fcf-0b40-4304-929f-7f2fa42f66d0.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
WK2XYI10QM	IBUPROFEN	15687-27-1	IBUPROFEN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197803	ibuprofen 100 MG in 5 mL Oral Suspension	PSN	998f2fcf-0b40-4304-929f-7f2fa42f66d0	17
197803	ibuprofen 20 MG/ML Oral Suspension	SCD	998f2fcf-0b40-4304-929f-7f2fa42f66d0	17
197803	ibuprofen 100 MG per 5 ML Oral Suspension	SY	998f2fcf-0b40-4304-929f-7f2fa42f66d0	17
197803	ibuprofen 200 MG per 10 ML Oral Suspension	SY	998f2fcf-0b40-4304-929f-7f2fa42f66d0	17
197803	ibuprofen 100 MG in 5 mL Oral Suspension	PSN	84c2b3e4-366c-433e-8a5e-14d606c5201e	3
197803	ibuprofen 20 MG/ML Oral Suspension	SCD	84c2b3e4-366c-433e-8a5e-14d606c5201e	3
197803	ibuprofen 100 MG per 5 ML Oral Suspension	SY	84c2b3e4-366c-433e-8a5e-14d606c5201e	3
197803	ibuprofen 200 MG per 10 ML Oral Suspension	SY	84c2b3e4-366c-433e-8a5e-14d606c5201e	3
197803	ibuprofen 100 MG in 5 mL Oral Suspension	PSN	9e9fb921-6b6a-422e-95b6-41d6b9047b80	1
197803	ibuprofen 100 MG in 5 mL Oral Suspension	PSN	d40a898e-524a-4f6e-83a7-bab4ce5218d1	1
197803	ibuprofen 100 MG in 5 mL Oral Suspension	PSN	287466a2-fe87-a911-e063-6394a90acb14	1
197803	ibuprofen 100 MG in 5 mL Oral Suspension	PSN	f52709a8-436f-d757-e053-2a95a90a94d6	1
197803	ibuprofen 100 MG in 5 mL Oral Suspension	PSN	07f01136-4649-4c5d-93c5-a8a7dbced9a1	1
197803	ibuprofen 100 MG in 5 mL Oral Suspension	PSN	f7a198ed-e7f1-47bd-a70f-cb637ccf4814	1
197803	ibuprofen 20 MG/ML Oral Suspension	SCD	f52709a8-436f-d757-e053-2a95a90a94d6	1
197803	ibuprofen 20 MG/ML Oral Suspension	SCD	f7a198ed-e7f1-47bd-a70f-cb637ccf4814	1
197803	ibuprofen 20 MG/ML Oral Suspension	SCD	d40a898e-524a-4f6e-83a7-bab4ce5218d1	1
197803	ibuprofen 20 MG/ML Oral Suspension	SCD	9e9fb921-6b6a-422e-95b6-41d6b9047b80	1
197803	ibuprofen 20 MG/ML Oral Suspension	SCD	07f01136-4649-4c5d-93c5-a8a7dbced9a1	1
197803	ibuprofen 20 MG/ML Oral Suspension	SCD	287466a2-fe87-a911-e063-6394a90acb14	1
197803	ibuprofen 100 MG per 5 ML Oral Suspension	SY	9e9fb921-6b6a-422e-95b6-41d6b9047b80	1
197803	ibuprofen 100 MG per 5 ML Oral Suspension	SY	d40a898e-524a-4f6e-83a7-bab4ce5218d1	1
197803	ibuprofen 100 MG per 5 ML Oral Suspension	SY	287466a2-fe87-a911-e063-6394a90acb14	1
197803	ibuprofen 100 MG per 5 ML Oral Suspension	SY	f52709a8-436f-d757-e053-2a95a90a94d6	1
197803	ibuprofen 100 MG per 5 ML Oral Suspension	SY	07f01136-4649-4c5d-93c5-a8a7dbced9a1	1
197803	ibuprofen 100 MG per 5 ML Oral Suspension	SY	f7a198ed-e7f1-47bd-a70f-cb637ccf4814	1
197803	ibuprofen 200 MG per 10 ML Oral Suspension	SY	9e9fb921-6b6a-422e-95b6-41d6b9047b80	1
197803	ibuprofen 200 MG per 10 ML Oral Suspension	SY	d40a898e-524a-4f6e-83a7-bab4ce5218d1	1
197803	ibuprofen 200 MG per 10 ML Oral Suspension	SY	287466a2-fe87-a911-e063-6394a90acb14	1
197803	ibuprofen 200 MG per 10 ML Oral Suspension	SY	f52709a8-436f-d757-e053-2a95a90a94d6	1
197803	ibuprofen 200 MG per 10 ML Oral Suspension	SY	f7a198ed-e7f1-47bd-a70f-cb637ccf4814	1
197803	ibuprofen 200 MG per 10 ML Oral Suspension	SY	07f01136-4649-4c5d-93c5-a8a7dbced9a1	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
45802-952-26	45802095226	1 BOTTLE in 1 CARTON (45802-952-26) / 120 mL in 1 BOTTLE	1 bottle	2004-12-28	0000-00-00	No	No	Current
45802-952-43	45802095243	473 mL in 1 BOTTLE (45802-952-43)	473 ml	2004-12-08	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ibuprofen Oral Suspension USP, 100 mg/5 mL	Kesin Pharma Corporation	2025-01-01	HUMAN PRESCRIPTION DRUG LABEL	1
Ibuprofen Oral Suspension USP, 100 mg/5 mL	Padagis Israel Pharmaceuticals Ltd	2024-12-31	HUMAN PRESCRIPTION DRUG LABEL	17
Ibuprofen Oral Suspension USP, 100 mg/5 mL	NuCare Pharmaceuticals,Inc.	2023-02-20	HUMAN PRESCRIPTION DRUG LABEL	1
Ibuprofen Oral Suspension USP, 100 mg/5 mL	Proficient Rx LP	2022-11-01	HUMAN PRESCRIPTION DRUG LABEL	1
Ibuprofen Oral Suspension USP, 100 mg/5 mL	PINNACLE PHARMA LLC	2021-04-14	HUMAN PRESCRIPTION DRUG LABEL	1
CORN SYRUP - Physicians Total Care, Inc.	Physicians Total Care, Inc.	2013-02-15	HUMAN OTC DRUG LABEL	3
Ibuprofen Oral Suspension USP, 100 mg/5 mL	STAT Rx USA LLC \| PSS World Medical Inc.	2012-10-12	HUMAN PRESCRIPTION DRUG LABEL	1
Ibuprofen Suspension 100 mg/5 mL	Rebel Distributors Corp	2010-09-29	HUMAN PRESCRIPTION DRUG LABEL	1

Ibuprofen

Additional Listing Data#

Related Records#

Active Ingredients#

Harmonized Identifiers#

DailyMed Product Concepts#

DailyMed Package Descriptions#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

Related Records#

Related UNII Ingredients#

DailyMed RxNorm Mappings#

Packages#

Related DailyMed Labels#