Over-the-counter drug · OTC MONOGRAPH DRUG
Dr. Simi Nighttime Cold and Flu NDC 85786-602
acetaminophen 325 mg, dextromethorphan hbr 15 mg, doxylamine succinate 6.25 mg · Dextromethorphan hydrobromide 15 mg/1 + 2 more ingredients · Capsule, Liquid filled · Oral · Farmacias De Similares TX LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 85786-602-24 | 85786060224 | 2 BLISTER PACK in 1 CARTON (85786-602-24) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACKMarketed from Mar 30, 2026 |
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)
- Dr. Simi Nighttime Cold and Flu
- Generic name (nonproprietary)
- acetaminophen 325 mg, dextromethorphan hbr 15 mg, doxylamine succinate 6.25 mg
- Active ingredients
- Dextromethorphan hydrobromide — 15 mg/1Doxylamine succinate — 6.25 mg/1Acetaminophen — 325 mg/1
- Dosage form
- Capsule, Liquid filled
- Route
- Oral
- Labeler
- Farmacias De Similares TX LLCNDC labeler code 85786
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 012
- Marketing start
- Listing expires
- Other FDA classes
- Histamine Receptor Antagonists (Mechanism)Sigma-1 Receptor Agonists (Mechanism)Uncompetitive NMDA Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 85786-602_4e5772ee-586d-6191-e063-6294a90a132dSPL ID 4e5772ee-586d-6191-e063-6294a90a132dSPL set ID 4e5772ee-586c-6191-e063-6294a90a132dRxCUI 1094549UNII 9D2RTI9KYH, V9BI9B5YI2, 362O9ITL9D
- Pharmacologic class
- Antihistamine; Sigma-1 Agonist; Uncompetitive N-methyl-D-aspartate Receptor Antagonist
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. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N485786060224followed by a unit qualifier and the quantityPackage 85786-0602-24. 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 temporarily relieves common cold/flu symptoms: ■ cough due to minor throat & bronchial irritation ■ sore throat ■ headache ■ minor aches & pains ■ fever ■ runny nose & sneezing
Excerpt only. Read the full label for complete information.
About NDC 85786-602
- What is NDC 85786-602?
- 85786-602 is the product NDC for Dr. Simi Nighttime Cold and Flu, Dextromethorphan hydrobromide 15 mg/1 + 2 more ingredients capsule, liquid filled, listed with the FDA by Farmacias De Similares TX LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Dr. Simi Nighttime Cold and Flu (Acetaminophen 325 mg, Dextromethorphan HBr 15 mg, Doxylamine Succinate 6.25 mg).
- What is the active ingredient?
- Dextromethorphan hydrobromide, Doxylamine succinate, Acetaminophen.
- Who is the labeler?
- Farmacias De Similares TX LLC, NDC labeler code 85786. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Dr. Simi Nighttime Cold and Flu?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
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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