Childrens Fluticasone Propionate
- Product NDC
- 72657-166
- 11-digit product format
- 726570166
- Labeler code
- 72657
- Product ID
- 72657-166_9aaa30cf-1e3b-4382-91dc-568067a4b0ac
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- fluticasone propionate
- Dosage form
- SPRAY, METERED
- Route
- NASAL
- Labeler
- GLENMARK THERAPEUTICS INC., USA
- Application
- ANDA218742
- Marketing category
- ANDA
- Marketing start
- 2026-06-30
- Substance
- FLUTICASONE PROPIONATE
- Active strength
- 50 ug/1
- Pharmacologic classes
- Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A218742-001 | FLUTICASONE PROPIONATE | FLUTICASONE PROPIONATE | 0.05MG/SPRAY | SPRAY, METERED / NASAL | 2026-03-16 |
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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A218742-001 | FLUTICASONE PROPIONATE | 0.05MG/SPRAY | SPRAY, METERED / NASAL | 2026-03-16 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A218742-001 | FLUTICASONE PROPIONATE | 0.05MG/SPRAY | SPRAY, METERED / NASAL | 2026-03-16 | caaa826d4ba7… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A218742-001 | FLUTICASONE PROPIONATE | 0.05MG/SPRAY | SPRAY, METERED / NASAL | 2026-03-16 | a50c72e98297… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Childrens Fluticasone Propionate
- Brand name suffix
- ALLERGY RELIEF
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| FLUTICASONE PROPIONATE | 50 ug/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| O2GMZ0LF5W | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1797907 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 9aaa30cf-1e3b-4382-91dc-568067a4b0ac | Available on FDA.report |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Childrens Fluticasone Propionate ALLERGY RELIEF | FLUTICASONE PROPIONATE | GLENMARK THERAPEUTICS INC., USA | 9aaa30cf-1e3b-4382-91dc-568067a4b0ac | 2026-06-30 | Warnings | 218742 ANDA218742 72657-166 |
| Fluticasone Propionate ALLERGY RELIEF | FLUTICASONE PROPIONATE | YYBA CORP | 5348075c-63ca-20f7-e063-6394a90a3f5c | 2026-06-12 | Warnings | 218742 ANDA218742 |
| Fluticasone Propionate ALLERGY RELIEF | FLUTICASONE PROPIONATE | GLENMARK THERAPEUTICS INC., USA | 5494106f-6792-409e-b63f-b63b98140959 | 2026-05-05 | Warnings | 218742 ANDA218742 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 72657-166-72 | 72657016672 | 1 BOTTLE in 1 CARTON (72657-166-72) / 72 SPRAY, METERED in 1 BOTTLE | 1 bottle | 2026-06-30 | No | No | Current |