NDC 69621-300

Diclofenac Sodium

3% Diclofenac Spray

Diclofenac Sodium is a Topical Aerosol, Metered in the Human Prescription Drug category. It is labeled and distributed by Shoreline Pharmaceuticals, Inc.. The primary component is Diclofenac Sodium.

• Product ID: 69621-300_2db8f138-1910-179e-e054-00144ff8d46c
• NDC: 69621-300
• Product Type: Human Prescription Drug
• Proprietary Name: Diclofenac Sodium
• Generic Name: 3% Diclofenac Spray
• Dosage Form: Aerosol, Metered
• Route of Administration: TOPICAL
• Marketing Start Date: 2016-01-07
• Marketing Category: UNAPPROVED DRUG OTHER / UNAPPROVED DRUG OTHER
• Labeler Name: Shoreline Pharmaceuticals, Inc.
• Substance Name: DICLOFENAC SODIUM
• Active Ingredient Strength: 30 mg/mL
• Pharm Classes: Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 69621-300-01

1 mL in 1 BOTTLE, SPRAY (69621-300-01)

• Marketing Start Date: 2016-01-07
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 69621-300-10 [69621030010]

Diclofenac Sodium AEROSOL, METERED

• Marketing Category: unapproved drug other
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2016-01-07
• Marketing End Date: 2016-01-15

NDC 69621-300-01 [69621030001]

Diclofenac Sodium AEROSOL, METERED

• Marketing Category: unapproved drug other
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2016-01-15
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
DICLOFENAC SODIUM	30 mg/mL

OpenFDA Data

• SPL SET ID: 278748fb-a004-4802-e054-00144ff8d46c
• Manufacturer:
  • Shoreline Pharmaceuticals, Inc.
• UNII:
  • QTG126297Q

Pharmacological Class

• Cyclooxygenase Inhibitors [MoA]
• Decreased Prostaglandin Production [PE]
• Anti-Inflammatory Agents
• Non-Steroidal [CS]
• Nonsteroidal Anti-inflammatory Drug [EPC]

NDC Crossover Matching brand name "Diclofenac Sodium" or generic name "3% Diclofenac Spray"

NDC	Brand Name	Generic Name
0115-1483	Diclofenac Sodium	Diclofenac Sodium
0168-0803	DICLOFENAC SODIUM	diclofenac sodium
0168-0844	DICLOFENAC SODIUM	diclofenac sodium
0228-2550	Diclofenac Sodium	Diclofenac Sodium
0228-2551	Diclofenac Sodium	Diclofenac Sodium
0363-1210	Diclofenac sodium	Diclofenac sodium
0363-1871	diclofenac sodium	diclofenac sodium
0378-0355	Diclofenac Sodium	Diclofenac Sodium
0378-6280	Diclofenac Sodium	diclofenac sodium
0378-6281	Diclofenac Sodium	diclofenac sodium
67544-899	Diclofenac Sodium	Diclofenac Sodium
68001-200	Diclofenac Sodium	Diclofenac Sodium
68001-201	Diclofenac Sodium	Diclofenac Sodium
68001-202	Diclofenac Sodium	Diclofenac Sodium
68001-279	Diclofenac Sodium	Diclofenac Sodium
68001-280	Diclofenac Sodium	Diclofenac Sodium
68001-281	Diclofenac Sodium	Diclofenac Sodium
68071-2045	Diclofenac Sodium	Diclofenac Sodium
68071-3159	Diclofenac sodium	Diclofenac sodium
68071-3325	Diclofenac Sodium	Diclofenac Sodium
68071-3132	Diclofenac Sodium	Diclofenac Sodium
68071-4158	Diclofenac Sodium	Diclofenac Sodium
68071-4382	Diclofenac Sodium	Diclofenac Sodium
68071-4246	Diclofenac sodium	Diclofenac sodium
68084-333	Diclofenac Sodium	Diclofenac Sodium
68151-0849	Diclofenac Sodium	Diclofenac Sodium
68151-2481	Diclofenac Sodium	Diclofenac Sodium
68180-538	Diclofenac Sodium	Diclofenac Sodium
0472-1783	Diclofenac Sodium	Diclofenac Sodium
68387-260	Diclofenac Sodium	Diclofenac Sodium
68382-999	Diclofenac sodium	Diclofenac sodium
68462-355	DICLOFENAC SODIUM	DICLOFENAC SODIUM
68682-103	Diclofenac Sodium	Diclofenac Sodium
68788-7270	Diclofenac Sodium	Diclofenac Sodium
68788-6368	Diclofenac Sodium	Diclofenac Sodium
68788-6388	Diclofenac Sodium	Diclofenac Sodium
68788-6831	Diclofenac sodium	Diclofenac sodium
68788-7225	Diclofenac sodium	Diclofenac sodium
68788-7097	Diclofenac Sodium	Diclofenac Sodium
68788-6952	Diclofenac Sodium	Diclofenac Sodium
68788-9231	Diclofenac Sodium	Diclofenac Sodium
68788-9389	Diclofenac Sodium	Diclofenac Sodium
68788-9523	Diclofenac Sodium	Diclofenac Sodium
68788-9175	Diclofenac Sodium	Diclofenac Sodium
68788-9185	Diclofenac Sodium	Diclofenac Sodium
68788-9435	DICLOFENAC SODIUM	DICLOFENAC SODIUM
69097-524	Diclofenac Sodium	Diclofenac Sodium
0527-2170	Diclofenac Sodium	Diclofenac Sodium
69621-300	Diclofenac Sodium	Diclofenac Sodium
69837-399	DICLOFENAC SODIUM	DICLOFENAC SODIUM