NDC 60505-0041-01 - Etodolac

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC: 60505-0041
Requested NDC: 60505-0041-01
Package NDCs from labels: 60505-0041-1, 60505-0041-2, 60505-0041-01
Manufacturer: REMEDYREPACK INC.
Effective date: 2026-09-16
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
ETODOLAC TABLETS, USP 400 mg and 500 mg Rx only	REMEDYREPACK INC.	2026-09-16	HUMAN PRESCRIPTION DRUG LABEL
ETODOLAC TABLETS, USP 400 mg and 500 mg Rx only	Apotex Corp. \| Apotex Inc.	2026-09-11	HUMAN PRESCRIPTION DRUG LABEL
Etodolac - St. Mary’s Medical Park Pharmacy	St. Mary’s Medical Park Pharmacy	2026-06-25	HUMAN PRESCRIPTION DRUG LABEL
ETODOLAC TABLETS, USP 400 mg Rx only	PD-Rx Pharmaceuticals, Inc.	2026-05-22	HUMAN PRESCRIPTION DRUG LABEL
ETODOLAC TABLETS, USP 400 mg Rx only	PD-Rx Pharmaceuticals, Inc.	2026-04-29	HUMAN PRESCRIPTION DRUG LABEL
ETODOLAC TABLETS, USP 400 mg Rx only	PD-Rx Pharmaceuticals, Inc.	2025-12-16	HUMAN PRESCRIPTION DRUG LABEL
Etodolac - Bryant Ranch Prepack	Bryant Ranch Prepack	2025-11-14	HUMAN PRESCRIPTION DRUG LABEL
ETODOLAC TABLETS, USP 400 mg and 500 mg Rx only	Preferred Pharmaceuticals Inc.	2025-03-24	HUMAN PRESCRIPTION DRUG LABEL
Etodolac - Advanced Rx Pharmacy of Tennessee, LLC	Advanced Rx Pharmacy of Tennessee, LLC	2024-12-31	HUMAN PRESCRIPTION DRUG LABEL
ETODOLAC TABLETS, USP 400 mg and 500 mg Rx only	RPK Pharmaceuticals, Inc.	2024-12-19	HUMAN PRESCRIPTION DRUG LABEL
Etodolac - Quality Care Products LLC	Quality Care Products LLC	2024-12-17	HUMAN PRESCRIPTION DRUG LABEL
Etodolac - Bryant Ranch Prepack	Bryant Ranch Prepack	2024-09-05	HUMAN PRESCRIPTION DRUG LABEL
Etodolac - Aphena Pharma Solutions - Tennessee, LLC	Aphena Pharma Solutions - Tennessee, LLC	2024-03-20	HUMAN PRESCRIPTION DRUG LABEL
Etodolac - A-S Medication Solutions	A-S Medication Solutions	2023-12-10	HUMAN PRESCRIPTION DRUG LABEL
Etodolac - Proficient Rx LP	Proficient Rx LP	2023-08-01	HUMAN PRESCRIPTION DRUG LABEL
ETODOLAC - DIRECT RX	DIRECT RX	2023-04-17	HUMAN PRESCRIPTION DRUG LABEL
Etodolac - A-S Medication Solutions	A-S Medication Solutions	2023-02-04	HUMAN PRESCRIPTION DRUG LABEL
NuDroxiPAK E-400 - NuCare Pharmaceuticals,Inc.	NuCare Pharmaceuticals,Inc.	2021-05-07	HUMAN PRESCRIPTION DRUG LABEL
ETODOLAC TABLETS, USP 400 mg and 500 mg Rx only	Preferred Pharmaceuticals Inc.	2020-05-18	HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
60505-0041-1	Etodolac	100 in 1 BOTTLE	TABLET, FILM COATED	100		16
60505-0041-2	Etodolac	500 in 1 BOTTLE	TABLET, FILM COATED	500		16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60505-0041	ETODOLAC TABLET, FILM COATED [APOTEX CORP.]	15	Current NDC, Legacy NDC, 2 package rows	20240809_4d682f98-1e8a-4c2b-6df3-169d2ed10dc1.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60505-0041-1	EA - Each	60505-0041	afbac5a4-38be-4949-a771-cbf64f0dcfb0	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ETODOLAC	ACTIVE INGREDIENT	2M36281008	ETODOLAC TABLET, FILM COATED [APOTEX CORP.]	5
ETODOLAC	ACTIVE MOIETY	2M36281008	ETODOLAC TABLET, FILM COATED [APOTEX CORP.]	5
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	ETODOLAC TABLET, FILM COATED [APOTEX CORP.]	5
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	ETODOLAC TABLET, FILM COATED [APOTEX CORP.]	5
HYPROMELLOSE 2208 (100 MPA.S)	INACTIVE INGREDIENT	B1QE5P712K	ETODOLAC TABLET, FILM COATED [APOTEX CORP.]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ETODOLAC TABLET, FILM COATED [APOTEX CORP.]	5
METHYLCELLULOSE (100 CPS)	INACTIVE INGREDIENT	4GFU244C4J	ETODOLAC TABLET, FILM COATED [APOTEX CORP.]	5
POLYETHYLENE GLYCOL 1500	INACTIVE INGREDIENT	1212Z7S33A	ETODOLAC TABLET, FILM COATED [APOTEX CORP.]	5
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ETODOLAC TABLET, FILM COATED [APOTEX CORP.]	5
Etodolac	ACTIVE INGREDIENT	2M36281008	ETODOLAC TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	4
etodolac	ACTIVE MOIETY	2M36281008	ETODOLAC TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	4
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	ETODOLAC TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	4
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	ETODOLAC TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	4
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	ETODOLAC TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ETODOLAC TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	4
METHYLCELLULOSE (100 CPS)	INACTIVE INGREDIENT	4GFU244C4J	ETODOLAC TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	4
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	ETODOLAC TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	4
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ETODOLAC TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	4
ETODOLAC	ACTIVE INGREDIENT	2M36281008	ETODOLAC TABLET, FILM COATED [STAT RX USA LLC]	1
ETODOLAC	ACTIVE INGREDIENT	2M36281008	ETODOLAC TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.]	1
ETODOLAC	ACTIVE MOIETY	2M36281008	ETODOLAC TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.]	1
ETODOLAC	ACTIVE MOIETY	2M36281008	ETODOLAC TABLET, FILM COATED [STAT RX USA LLC]	1
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	ETODOLAC TABLET, FILM COATED [STAT RX USA LLC]	1
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	ETODOLAC TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.]	1
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	ETODOLAC TABLET, FILM COATED [STAT RX USA LLC]	1
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	ETODOLAC TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.]	1
HYPROMELLOSE 2208 (100 MPA.S)	INACTIVE INGREDIENT	B1QE5P712K	ETODOLAC TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	ETODOLAC TABLET, FILM COATED [STAT RX USA LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ETODOLAC TABLET, FILM COATED [STAT RX USA LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ETODOLAC TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.]	1
METHYLCELLULOSE (100 CPS)	INACTIVE INGREDIENT	4GFU244C4J	ETODOLAC TABLET, FILM COATED [STAT RX USA LLC]	1
METHYLCELLULOSE (100 MPA.S)	INACTIVE INGREDIENT	4GFU244C4J	ETODOLAC TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.]	1
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	ETODOLAC TABLET, FILM COATED [STAT RX USA LLC]	1
POLYETHYLENE GLYCOL 1500	INACTIVE INGREDIENT	1212Z7S33A	ETODOLAC TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ETODOLAC TABLET, FILM COATED [STAT RX USA LLC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ETODOLAC TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.]	1

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 2 of 241 · 4,802 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Orajel 4X Medicated Toothache and Gum PM Cream	BENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDE	Church & Dwight Co., Inc.	5a1cdaf4-3388-280c-e063-6294a90ac70f	2026-08-31	Warnings	Exact identifier unii: L7T10EIP3A
REINREUDE SMELLING SALTS	MENTHOL 15% SMELLING SALTS	Hubei Minxin Pharmaceutical Co., Ltd.	5a539219-f9b8-5e94-e063-6294a90a2593	2026-08-31	Warnings	Exact identifier unii: L7T10EIP3A
SERYNTH SMELLING SALTS	MENTHOL 15% SMELLING SALTS	Hubei Minxin Pharmaceutical Co., Ltd.	5a5405f9-9881-e547-e063-6294a90a0d10	2026-08-31	Warnings	Exact identifier unii: L7T10EIP3A
EAYONYUMT NECK PAIN RELIEF	MENTHOL	Wuhan Ruihengjie Technology Co., Ltd.	5a450e68-07a7-a4bb-e063-6294a90a97c9	2026-08-30	Warnings	Exact identifier unii: L7T10EIP3A
EAYONYUM BACK PAIN RELIEVING	MENTHOL	Wuhan Ruihengjie Technology Co., Ltd.	5a458280-4f9c-5af6-e063-6394a90acb2e	2026-08-30	Warnings	Exact identifier unii: L7T10EIP3A
EAYONYUM KNEE PAIN RELIEVING	MENTHOL	Wuhan Ruihengjie Technology Co., Ltd.	5a45d19f-c753-71eb-e063-6294a90a4805	2026-08-30	Warnings	Exact identifier unii: L7T10EIP3A
SYLVIRENE SMELLING SALTS	MENTHOL 15% SMELLING SALTS	Hubei Minxin Pharmaceutical Co., Ltd.	5a4fd689-2113-f15a-e063-6394a90a45ad	2026-08-30	Warnings	Exact identifier unii: L7T10EIP3A
Rhinoost SMELLING SALTS	MENTHOL 15% SMELLING SALTS	Hubei Minxin Pharmaceutical Co., Ltd.	5a296baa-c101-3192-e063-6394a90aa2b0	2026-08-29	Warnings	Exact identifier unii: L7T10EIP3A
LUCKSKY SMELLING SALTS	MENTHOL 15% SMELLING SALTS	Hubei Minxin Pharmaceutical Co., Ltd.	5a29ee19-8b6d-b4fa-e063-6394a90ad81d	2026-08-29	Warnings	Exact identifier unii: L7T10EIP3A
Flobow SMELLING SALTS	MENTHOL 15% SMELLING SALTS	Hubei Minxin Pharmaceutical Co., Ltd.	5a2aa169-90b5-417f-e063-6394a90aa278	2026-08-29	Warnings	Exact identifier unii: L7T10EIP3A
Hoxlbin SMELLING SALTS	MENTHOL 15% SMELLING SALTS	Hubei Minxin Pharmaceutical Co., Ltd.	5a17b116-d573-1c4a-e063-6394a90a499b	2026-08-28	Warnings	Exact identifier unii: L7T10EIP3A
Orajel 4X Medicated Toothache and Gum	BENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDE	Church & Dwight Co., Inc.	5a1b4133-0eac-2f8f-e063-6394a90af8f6	2026-08-28	Warnings	Exact identifier unii: L7T10EIP3A
Chest Rub	CAMPHOR, EUCALYPTUS OIL, MENTHOL	Your Military Exchanges	13fcc43c-bdda-4b65-b6d7-23b39e683651	2026-08-28	Warnings, Adverse reactions	Exact identifier unii: L7T10EIP3A
Sinsinpas Arex Pain Relieving Patch, Medium	CAMPHOR, MENTHOL, METHYL SALICYLATE	Sinsin Pharmaceutical Co., Ltd.	46453ef2-512b-4852-e063-6394a90a8912	2026-08-28	Warnings	Exact identifier unii: LAV5U5022Y
Sinsinpas arex patch large	CAMPHOR, MENTHOL, METHYL SALICYLATE	Sinsin Pharmaceutical Co., Ltd.	47c242da-56cd-bea1-e063-6394a90a41de	2026-08-28	Warnings	Exact identifier unii: LAV5U5022Y
Unikinesys SMELLING SALTS	MENTHOL 15% SMELLING SALTS	Hubei Minxin Pharmaceutical Co., Ltd.	5a275076-b75a-7d2c-e063-6294a90ad222	2026-08-28	Warnings	Exact identifier unii: L7T10EIP3A
TideFresh SMELLING SALTS	MENTHOL 15% SMELLING SALTS	Hubei Minxin Pharmaceutical Co., Ltd.	5a27a35c-8c6b-d298-e063-6294a90a1389	2026-08-28	Warnings	Exact identifier unii: L7T10EIP3A
Nrmrqz SMELLING SALTS	MENTHOL 15% SMELLING SALTS	Hubei Minxin Pharmaceutical Co., Ltd.	5a27f471-e54e-cbbf-e063-6394a90aa804	2026-08-28	Warnings	Exact identifier unii: L7T10EIP3A
etodolac	ETODOLAC	A-S Medication Solutions	1e04a6b7-a671-4999-ab03-aa1a243aac03	2026-08-28	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 2M36281008
MZANK SUNSCREEN DAILY ULTIMATE PROTECTION SPF50	SUNSCREEN SPF50	Guangzhou Meixi Biotechnology Co., Ltd.	5a0b4bd2-f6ad-35dc-e063-6294a90a8a66	2026-08-27	Warnings	Exact identifier unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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