NasalCrom
- Product NDC
- 52183-199
- 11-digit product format
- 521830199
- Labeler code
- 52183
- Product ID
- 52183-199_dad5f3da-ce07-430e-89a3-bac96fc16527
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- cromolyn sodium
- Dosage form
- SPRAY, METERED
- Route
- NASAL
- Labeler
- Prestige Brands Holdings, Inc.
- Application
- ANDA075702
- Marketing category
- ANDA
- Marketing start
- 2009-10-29
- Substance
- CROMOLYN SODIUM
- Active strength
- 5.2 mg/1
- Pharmacologic classes
- Decreased Histamine Release [PE], Mast Cell Stabilizer [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- NasalCrom
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CROMOLYN SODIUM | 5.2 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | Q2WXR1I0PK |
| Rxcui | 1797851, 1797853 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 52183-199-13 | NasalCrom | 1 in 1 CARTON | SPRAY, METERED | 1 | | 13 |
| 52183-199-13 | NasalCrom | 200 in 1 BOTTLE, PUMP | SPRAY, METERED | 200 | | 13 |
| 52183-199-14 | NasalCrom | 1 in 1 CARTON | SPRAY, METERED | 1 | | 13 |
| 52183-199-14 | NasalCrom | 100 in 1 BOTTLE, PUMP | SPRAY, METERED | 100 | | 13 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| CROMOLYN SODIUM | ACTIVE INGREDIENT | Q2WXR1I0PK | NASALCROM (CROMOLYN SODIUM) SPRAY, METERED [PRESTIGE BRANDS HOLDINGS, INC.] | 3 | |
| CROMOLYN | ACTIVE MOIETY | Y0TK0FS77W | NASALCROM (CROMOLYN SODIUM) SPRAY, METERED [PRESTIGE BRANDS HOLDINGS, INC.] | 3 | |
| BENZALKONIUM CHLORIDE | INACTIVE INGREDIENT | F5UM2KM3W7 | NASALCROM (CROMOLYN SODIUM) SPRAY, METERED [PRESTIGE BRANDS HOLDINGS, INC.] | 3 | |
| EDETATE DISODIUM | INACTIVE INGREDIENT | 7FLD91C86K | NASALCROM (CROMOLYN SODIUM) SPRAY, METERED [PRESTIGE BRANDS HOLDINGS, INC.] | 3 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | NASALCROM (CROMOLYN SODIUM) SPRAY, METERED [PRESTIGE BRANDS HOLDINGS, INC.] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 52183-199 | NASALCROM (CROMOLYN SODIUM) SPRAY, METERED [PRESTIGE BRANDS HOLDINGS, INC.] | 11 | Current NDC, Legacy NDC, 4 package rows | 20231206_b34d36ca-4df4-458c-af0f-c0d0c9a025d9.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 52183-199-13 | 52183019913 | 1 BOTTLE, PUMP in 1 CARTON (52183-199-13) / 200 SPRAY, METERED in 1 BOTTLE, PUMP | 2009-10-29 | 0000-00-00 | No | No | Current |
| 52183-199-14 | 52183019914 | 1 BOTTLE, PUMP in 1 CARTON (52183-199-14) > 100 SPRAY, METERED in 1 BOTTLE, PUMP | 2009-10-29 | 0000-00-00 | No | No | Current |