NDC codes

FDA NDC Directory
Product NDC (as listed)76314-003Labeler and product segments. Claims need a package NDC.
Product NDC at billing width76314-0003Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
76314-003-0176314000301763140003014.43 mL in 1 PACKAGE (76314-003-01)Marketed from Nov 17, 2011
76314-003-0276314000302763140003021 mL in 1 PACKET (76314-003-02)Marketed from Nov 17, 2011

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)
FixMySkin Healing Balm Unflavored
Generic name (nonproprietary)
hydrocortisone
Active ingredients
Hydrocortisone — 10 mg/mL
Dosage form
Ointment
Route
Topical
Labeler
Lovely Skin, Inc.NDC labeler code 76314
Product type
Over-the-counter drug
Marketing category
OTC monograph drugApplication M 017
Marketing start
Listing expires
Other FDA classes
Corticosteroid Hormone Receptor Agonists (Mechanism)
Identifiers
Product ID 76314-003_502555d0-907a-6275-e063-6394a90a0352SPL ID 502555d0-907a-6275-e063-6394a90a0352SPL set ID 9ff8db07-ad6d-4865-a534-94bd8312957eRxCUI 203105UNII WI4X0X7BPJUPC 0857592008972
Pharmacologic class
Corticosteroid

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

N476314000301 followed by a unit qualifier and the quantity

Package 76314-0003-01. 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 For the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to eczema, psoriasis, seborrheic dermatitis, insect bites, poison oak, or poison sumac, soaps, detergents, cosmetics, and jewelry, and for external genital and feminine itching, and external analgesic. Other uses of this product should only be under the advice and supervision of a doctor.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 76314-003

What is NDC 76314-003?
76314-003 is the product NDC for FixMySkin Healing Balm Unflavored, Hydrocortisone 10 mg/mL ointment, listed with the FDA by Lovely Skin, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
FixMySkin Healing Balm Unflavored (Hydrocortisone).
What is the active ingredient?
Hydrocortisone.
Who is the labeler?
Lovely Skin, Inc., NDC labeler code 76314. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for FixMySkin Healing Balm Unflavored?
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 017

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under M 017
ProductStrengthForm · routeLabelerProduct NDC
Aosi Healthcare Burnlidocaine hydrochloride, benzalkonium chlorideLidocaine hydrochloride .5 g/100g; Benzalkonium chloride .13 g/100gCreamTopicalNantong Health & Beyond Hygienic Products Inc.43473-055
Satohap Cool Typecamphor, menthol, methyl salicylateCamphor (Synthetic) 5 g/100mL + 2 more ingredientsLotionTopicalSato Pharmaceutical Co., Ltd.49873-620
Wegmans Aloe After Sun Gel with Lidocaine HCl External Analgesiclidocaine hydrochlorideLidocaine hydrochloride 8 mg/gGelTopicalWEGMANS FOOD MARKETS INC47124-129
Walgreens Burn Padburn padLidocaine 4.1 g/100gPatchTopicalWalgreens0363-2789
Extra Large Cool and Heat PatchmentholMenthol 5 g/100gPatchTopicalWalgreen Company0363-9905
Maximum Strength Cortisone Cream with Aloehydrocortisone creamHydrocortisone 1 g/100gCreamTopicalCVS Pharmacy69842-630
hydrocortisoneHydrocortisone 1 g/100gOintmentTopicalBryant Ranch Prepack72162-2284
Menthol, CamphorMenthol 10 g/100g; Camphor (Natural) 3 g/100gCreamTopicalSUNSET NOVELTIES, INC72937-103
Mineral Ice Methol Pain Reliefmenthol 10.5 %Menthol 10.5 g/100gSprayTopicalSunflora Inc73240-905
Equate Hydrocortisone TopicalhydrocortisoneHydrocortisone .01 g/gCreamTopicalWalMart79903-091
MorovanlidocaineLidocaine 4 g/100gCreamTopicalHONG KONG UNORDERED TRADING CO., LIMITED87800-2624
Eucerin Skin Calming Itch Relief TreatmentmentholMenthol .1 g/100mLLotionTopicalBeiersdorf Inc10356-357
Cortizone 10 Intensive HealinghydrocortisoneHydrocortisone 10 mg/gCreamTopicalChattem, Inc.41167-0035
Satogesic HotcapsaicinCapsaicin .25 mg/1PatchTopicalSato Pharmaceutical Co., Ltd.49873-608
CAREALL Hydrocortisone Maximum StrengthhydrocortisoneHydrocortisone .01 g/gCreamTopicalNew World Imports, Inc.51824-197
CVS Cold and Hot Pain Relief Drylidocaine, mentholMenthol, Unspecified form 10 mg/g; Lidocaine 40 mg/gSprayTopicalCVS Pharmacy51316-483
Pain Relieving Cream Lidocainebenzyl alcohol, lidocaine hciLidocaine hydrochloride 4 g/100g; Benzyl alcohol 10 g/100gCreamTopicalTrifecta Pharmaceuticals USA LLC69396-139
CVS Anti-Itchcamphor, mentholCamphor (Synthetic) .5 g/100g; Menthol .5 g/100gLotionTopicalCVS69842-626
External Analgesiccamphor, capsicum, mentholCamphor (Synthetic) 96 mg/g + 2 more ingredientsPatchTopicalHmong 2170927-001
Doctor Hoys Pain Relief Gelmenthol, camphor (synthetic)Menthol 50 mg/mL; Camphor (Synthetic) 50 mg/mLGelTopicalDynamic Blending Specialists, Inc.75638-010

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