Over-the-counter drug · OTC MONOGRAPH DRUG
Signature Care Hemorrhoidal NDC 21130-789
mineral oil, petrolatum, and phenylephrine hci · Petrolatum 749 mg/g + 2 more ingredients · Ointment · Topical · Better Living Brands, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 21130-789-14 | 21130078914 | 1 TUBE in 1 CARTON (21130-789-14) / 28 g in 1 TUBEMarketed from Jan 21, 2016 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Signature Care Hemorrhoidal
- Generic name (nonproprietary)
- mineral oil, petrolatum, and phenylephrine hci
- Active ingredients
- Petrolatum — 749 mg/gPhenylephrine hydrochloride — 2.5 mg/gMineral oil — 140 mg/g
- Dosage form
- Ointment
- Route
- Topical
- Labeler
- Better Living Brands, LLC
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 015
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha1-Agonists (Mechanism)
- Identifiers
- Product ID 21130-789_4a197084-aa10-02ef-e063-6394a90a1e46SPL ID 4a197084-aa10-02ef-e063-6394a90a1e46SPL set ID 3c8b43f3-6e1e-499e-ba71-ffdf836f6743RxCUI 1372298UNII 4T6H12BN9U, 04JA59TNSJ, T5L8T28FGPUPC 0321130789826
- Pharmacologic class
- alpha-1 Adrenergic Agonist
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Topical products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N421130078914followed by a unit qualifier and the quantityPackage 21130-0789-14. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Directions adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe. Gently dry by patting or blotting with a tissue or a soft cloth before applying ointment. when first opening the tube, puncture foil seal with top end of cap apply to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement interacetal use: remove cover from applicator, attach applicator to tube, lubricate applicator well and gently insert applicator into thoroughly cleanse applicator after each use and replace cover also apply ointment to external area regular use provides continual therapy for relief of symptoms children unde…
Excerpt only. Read the full label for complete information.
Other NDCs under M 015
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Chamosynbarrier cream | Menthol 1 mg/g; Zinc oxide 200 mg/g | OintmentTopical | Links Medical Products | 51028-002 |
| Hemorrhoid Relief Creamlidocaine 5% anorectal | Lidocaine 50 mg/g | CreamTopical | ALAINA HEALTHCARE PRIVATE LIMITED | 73492-712 |
| Hemorrhoidalcocoa butter, phenylephrine hcl | Cocoa butter 2.39 g/1; Phenylephrine hydrochloride 6.75 mg/1 | SuppositoryRectal | Amerisourcebergen Drug Corporation | 46122-777 |
| Family wellnessmineral oil, petrolatum, phenylephrine hcl | Mineral oil 14 g/100g + 2 more ingredients | OintmentTopical | FRONT PHARMACEUTICAL PLC | 69571-006 |
| Kroger Medicated Wipes Hemorrhoidal Wipe With Witch Hazel And Aloewitch hazel cloth | Witch hazel .5 g/g | SwabTopical | The Kroger Co. | 30142-791 |
| TN Dickinsons Witch Hazel Hemorrhoidal Padswitch hazel | Witch hazel 1.2 g/1 | ClothTopical | Dickinson Brands Inc. | 52651-003 |
| T.N. Dickinsons Witch Hazel Medicated Cooling Pads Hemorrhoidal Reliefwitch hazel | Witch hazel .034 g/1 | ClothTopical | Dickinson Brands Inc. | 52651-010 |
| Norms Hemorrhoidphenylephrine hydrochloride, witch hazel | Witch hazel 50 g/100g; Phenylephrine hydrochloride .25 g/100g | SprayTopical | Totally Normal Company | 85996-135 |
| hemorrhoidalcocoa butter, phenylephrine hcl | Cocoa butter 2211 mg/1; Phenylephrine hydrochloride 6.5 mg/1 | SuppositoryRectal | H E B | 37808-279 |
| Dermatool Hemorrhoidalglycerin, lidocaine, petrolatum, phenylephrine hcl | Lidocaine 5 g/100g + 3 more ingredients | CreamTopical | Papalo Group LLC | 84728-413 |
| Norms Medicated Wipeswitch hazel | Witch hazel .5 g/g | ClothTopical | Totally Normal Company | 85996-001 |
| Walgreens Hemorrhoidal Pain Reliefglycerin 14.4%, lidocaine 5%, petrolatum 15%, phenylephrine hcl 0.25% | Lidocaine 5 g/100g + 3 more ingredients | CreamTopical | Walgreens | 0363-1217 |
| Norms Hemorrhoid Wipeswitch hazel | Witch hazel .5 g/g | ClothTopical | Totally Normal Company | 85996-002 |
| Norms Hemorrhoidglycerin, lidocaine, petrolatum, phenylephrine hcl | Lidocaine 5 g/100g + 3 more ingredients | CreamTopical | Totally Normal Company | 85996-173 |
| ReVIVOL-XRphenylephrine hydrochloride | Phenylephrine hydrochloride 6.25 mg/1 | SuppositoryRectal | Unipack LLC | 43749-432 |
| Preparation Hcocoa butter, phenylephrine hydrochloride | Cocoa butter 2211 mg/1; Phenylephrine hydrochloride 6.25 mg/1 | SuppositoryRectal | Haleon US Holdings LLC | 0573-2883 |
| FAMILY Wellness MEDICATED HEMORRHOIDAL WIPESwitch hazel | Witch hazel 50 g/100mL | ClothTopical | Family Dollar Stores, Inc | 55319-774 |
| Walgreens Hemorrhoidalhemorrhoidal rectal suppositories | Cocoa butter 2211 mg/1; Phenylephrine hydrochloride 6.25 mg/1 | SuppositoryRectal | Walgreens | 0363-0476 |
| Recticarelidocaine and glycerin | Lidocaine 50 mg/g; Glycerin 200 mg/g | ClothTopical | Ferndale Laboratories, Inc. | 0496-0980 |
| Kroger Hemorrhoidglycerin, lidocaine, petrolatum, phenylephrine hcl | Lidocaine 5 g/100g + 3 more ingredients | CreamTopical | Kroger Company | 30142-713 |
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