Over-the-counter drug · OTC MONOGRAPH DRUG
12 Hour Original Nasal Decongestant (Nasal spray) NDC 11527-140
Oxymetazoline hydrochloride 50 mg/100mL · Liquid · Nasal · Sheffield Pharmaceuticals LLC
NDC codes
FDA NDC DirectoryProduct NDC (as listed)11527-140Labeler and product segments. Claims need a package NDC.
Product NDC at billing width11527-0140Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 11527-140-55 | 11527014055 | 1 BOTTLE, SPRAY in 1 CARTON (11527-140-55) / 30 mL in 1 BOTTLE, SPRAYMarketed from May 30, 2014 |
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)
- 12 Hour Original Nasal Decongestant
- Generic name (nonproprietary)
- nasal spray
- Active ingredients
- Oxymetazoline hydrochloride — 50 mg/100mL
- Dosage form
- Liquid
- Route
- Nasal
- Labeler
- Sheffield Pharmaceuticals LLCNDC labeler code 11527
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 012
- Marketing start
- Listing expires
- Other FDA classes
- Imidazolines (Chemical structure)Increased Sympathetic Activity (Physiologic effect)Vasoconstriction (Physiologic effect)
- Identifiers
- Product ID 11527-140_36eb3a35-be6c-4e5f-a189-2575f5dd142bSPL ID 36eb3a35-be6c-4e5f-a189-2575f5dd142bSPL set ID cea0ce76-ae75-4484-a7c2-ff1086e9d8b0RxCUI 1000990UNII K89MJ0S5VY
- Pharmacologic class
- Vasoconstrictor
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. Nasal products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N411527014055followed by a unit qualifier and the quantityPackage 11527-0140-55. 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)
Uses Tempoarily relieves nasal congestion due to: common cold hay fever sinusitis upper respiroty allergies Shribnk swollen membranes so you can breathemore freely
Excerpt only. Read the full label for complete information.
About NDC 11527-140
- What is NDC 11527-140?
- 11527-140 is the product NDC for 12 Hour Original Nasal Decongestant, Oxymetazoline hydrochloride 50 mg/100mL liquid, listed with the FDA by Sheffield Pharmaceuticals LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- 12 Hour Original Nasal Decongestant (Nasal Spray).
- What is the active ingredient?
- Oxymetazoline hydrochloride.
- Who is the labeler?
- Sheffield Pharmaceuticals LLC, NDC labeler code 11527. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for 12 Hour Original Nasal Decongestant?
- 1 other product NDC are listed under this name. See all 12 Hour Original Nasal Decongestant NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other 12 Hour Original Nasal Decongestant products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| 12 Hour Original Nasal Decongestantnasal spray | Oxymetazoline hydrochloride 50 mg/100mL | LiquidNasal | WinCo Foods LLC | 67091-378 | 67091-0378-08 |
Other NDCs under M 012
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 |
|---|---|---|---|---|
| Childrens Benadryl ALLERGYdiphenhydramine hydrochloride | Diphenhydramine hydrochloride 12.5 mg/5mL | SolutionOral | Kenvue Brands LLC | 50580-534 |
| Cold Maxacetaminophen, dextromethorphan hydrobromide, and phenylephrine hydrochloride | Acetaminophen 325 mg/1 + 2 more ingredients | Tablet, CoatedOral | DISCOUNT DRUG MART | 53943-138 |
| Kroger DayTime Cold and Flu SOFTGELacetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride | Acetaminophen 325 mg/1 + 2 more ingredients | Capsule, Liquid filledOral | The Kroger Co. | 59450-046 |
| CVS Overnight Cold and Flu Clear and Coolacetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride, and triprolidine hydrochloride | Acetaminophen 650 mg/20mL + 3 more ingredients | SolutionOral | CVS PHARMACY, INC | 69842-966 |
| Sinus Head Congestionacetaminophen, phenylephrine hydrochloride | Acetaminophen 325 mg/1; Phenylephrine hydrochloride 5 mg/1 | Capsule, Liquid filledOral | VIVUNT PHARMA LLC | 82706-025 |
| Leader Cough Drops Vanilla Honeymenthol | Menthol, Unspecified form 2.5 mg/1 | LozengeOral | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 83698-692 |
| Allergy Reliefdiphenhydramine hydrochloride | Diphenhydramine hydrochloride 25 mg/1 | Tablet, CoatedOral | HEB | 37808-590 |
| Oxymetazoline Hydrochloride | Oxymetazoline hydrochloride .05 g/100mL | SprayNasal | Bi-Mart | 37835-996 |
| Vaporxcamphor (synthetic), eucalyptus oil, and menthol | Camphor (Synthetic) .048 g/g + 2 more ingredients | OintmentTopical | AKRON PHARMA INC | 71399-4589 |
| Global Care 4Oz Vapor Rubmenthol, camphor, eucalyptus oil | Menthol 1 g/100g + 2 more ingredients | OintmentTopical | GLOBAL IMPORT SALES LLC | 72146-008 |
| Adult Allergy Reliefcalmco allergy relief | Diphenhydramine hydrochloride 25 mg/1 | Bar, ChewableOral | CalmCo | 73282-2520 |
| Severe cold and flu Nighttimeacetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hci | Acetaminophen 650 mg/30mL + 3 more ingredients | LiquidOral | P & L Development, LLC | 49580-4160 |
| Tylenol Cold Plus Flu Severe Day and Tylenol Cold Plus Flu Plus Cough Night 2-packacetaminophen, dextromethorphan hydrobromide, doxylamine succinate, and guaifenesin, phenylephrine hydrochloride | — | Kit | Kenvue Brands LLC | 50580-526 |
| Daytime and Nighttimeacetaminophen, guaifenesin, dextromethorphan hbr, doxylamine succinate | — | KitOral | CVS HEALTH CORP | 51316-961 |
| Alka-Seltzer Plus Severe Cold Powerfast Fizz Nightaspirin, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine bitartrate | Aspirin 500 mg/1 + 3 more ingredients | Tablet, EffervescentOral | Bayer HealthCare LLC. | 0280-0021 |
| Sinus Pressure plus Pain PEacetaminophen and phenylephrine hydrochloride | Acetaminophen 325 mg/1; Phenylephrine hydrochloride 5 mg/1 | Tablet, CoatedOral | VALU MERCHANDISERS COMPANY | 63941-220 |
| Daytime Cold And Flu Multi-Symptom Reliefacetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride | Acetaminophen 325 mg/1 + 2 more ingredients | CapsuleOral | Chain Drug Consortium, LLC | 68016-877 |
| Sugar Free Cough Drops Black Cherrymenthol | Menthol 5.8 mg/1 | PastilleOral | Cardinal Health 110, Inc. | 70000-0643 |
| Multi-Symptom Cold childrensdextromethorphan hbr, guaifenesin, phenylephrine hcl | Dextromethorphan hydrobromide 5 mg/5mL + 2 more ingredients | SolutionOral | WALMART INC. | 79903-176 |
| AXIV DayTime - Liquidacetaminophen, dextromethorphan hydrobromide | Acetaminophen 650 mg/30mL; Dextromethorphan hydrobromide 20 mg/30mL | LiquidOral | VIVUNT PHARMA LLC | 82706-022 |
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