NANO PPC

Product NDC
60709-107
11-digit product format
607090107
Labeler code
60709
Product ID
60709-107_f1811ea6-640d-40bf-ae08-05d9e9d476ad
Type
HUMAN OTC DRUG
Nonproprietary name
Caffeine
Dosage form
CREAM
Route
TOPICAL
Labeler
YBK Investment, INC
Application
part343
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2013-11-15
Marketing end
0000-00-00
Substance
VANILLYL BUTYL ETHER; CAFFEINE
Active strength
3 mg/250mL; mg/250mL
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct60709-107IInactivated by FDA2026-07-31
excluded packagepackage60709-10760709-107-02IInactivated by FDA2026-07-31

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Good Sense Pain and FeverACETAMINOPHENPreferred Pharmaceuticals Inc.7dbd0a2d-8597-4010-bfe2-94a8d145ca572026-03-27WarningsExact identifier
AcetaminophenACETAMINOPHENAphena Pharma Solutions - Tennessee, LLC89134c3e-ec5b-4a57-952a-98d6c6cff7c22019-02-26WarningsExact identifier
CounterAct PMACETAMINOPHEN AND DIPHENHYDRAMINEMelaleuca, Inc.7f9a0062-0e86-1deb-e053-2a91aa0a91882019-01-18WarningsExact identifier
Low Dose Miniprin Enteric Safety CoatedASPIRINTime-Cap Labs, Inc5a38a643-55b0-4a6c-84e1-ee23744351142018-12-19WarningsExact identifier
Low Dose Aspirin Enteric Safety CoatedASPIRINTime-Cap Labs, Inc55d645bb-8645-4984-a7b9-3e6eed8c64122018-12-17WarningsExact identifier
ACETAMINOPHENACETAMINOPHENTIME CAP LABORATORIES, INC2569383a-4a05-4ddb-852e-b37e487ffcde2018-12-17WarningsExact identifier
Low Dose Aspirin Enteric Safety CoatedASPIRINTime-Cap Labs, Inc9cb0c2df-5e72-42c5-ae93-144201fd263c2018-12-17WarningsExact identifier
ASPIRIN EXTRA STRENGTHASPIRINTime-Cap Labs, Incefc7d42a-241a-422d-bc08-be2f5f774b622018-12-17WarningsExact identifier
aspirin low dose enteric coatedASPIRINTime-Cap Labs, Inc5aaf8b66-b00e-4bc8-972c-bbe6825284fb2018-12-17WarningsExact identifier
aspirin low dose enteric coatedASPIRINTime-Cap Labs, Inc7146c505-2469-4bc2-9e1e-ceb60951c8ae2018-12-17WarningsExact identifier
Comfort-TimeACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATETime Cap Labs, Ince94a26a2-36e5-4e1e-aea1-24e035c980432018-12-14WarningsExact identifier
Aspirin Delayed ReleaseASPIRINTime-Cap Labs, Inc70d8ba6c-8dfe-402a-817d-22544141d1602018-12-14WarningsExact identifier
Geritrex AspirinASPIRINGeritrex LLC93fb4359-c93d-46c4-b36e-611b829f514c2018-10-10WarningsExact identifier
Pain Relief PMACETAMINOPHEN PMVelocity Pharmac1c1de91-6a54-4d91-93a9-b6be6d7c7dfb2018-05-14WarningsExact identifier
AcetaminophenACETAMINOPHENVelocity Pharma LLCbba2ddc5-19e0-4f11-8ff7-7dd7c2d53b502018-05-14WarningsExact identifier
AspirinASPIRINAphena Pharma Solutions - Tennessee, LLC49f46b08-b2fe-4e4d-b235-983dab9740cc2018-02-18WarningsExact identifier
AcetaminophenACETAMINOPHENAdvance Pharmaceutical Inc.3793a17e-13bf-4d27-b8fa-6753b760f8202017-12-22WarningsExact identifier
APAPACETAMINOPHENAdvance Pharmaceutical Inc.aba26f0a-94e4-4919-a3b0-033e3a9598ef2017-12-22WarningsExact identifier
APAPACETAMINOPHENAdvance Pharmaceutical Inc.5c75dc7f-06ae-440e-90ed-d7753eaa786e2017-12-22WarningsExact identifier
Extra Strength AcetaminophenACETAMINOPHENPuraCap Pharmaceutical LLCf3c57374-1408-4459-a4de-ad12c2fc6b612017-11-09WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes • more than 5 doses in 24 hours, which is the maximum daily amount • with other drugs containing acetaminophen Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: • skin reddening • blisters • rash If a skin reaction occurs, stop use and seek medical help right away. Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. Do not use • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. • if your child has ever had an allergic reaction to this product or any of its ingredients Ask a doctor before use if your child has liver disease Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin When using this product do not exceed recommended dose (see overdose warning) Stop use and ask a doctor if • pain gets worse or lasts more than 5 days • fever gets worse or lasts more than 3 days • new symptoms occur • redness or swelling is present These could be signs of a serious condition. Keep out of reach of children. Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical even if you do not notice any signs or symptoms.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
2dc76302-91c0-4c35-ad78-99adfb049c4bProduct name120200603
e6065d4b-5ae1-476f-a40e-f2851cbb5d2bProduct name220180221
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508
d223c173-c39b-d764-47d4-d671d3088815Product name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
60709-107-022019-11-27C16284748780-19855e2a2-38a3-60a7-e053-dbdaa90a05bdNANO-PPC 250mL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60709-107-01NANO PPC250 mL in 1 TUBECREAM2501
60709-107-02NANO PPC1 in 1 CARTONCREAM11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CAFFEINEACTIVE INGREDIENT3G6A5W338ENANO PPC (CAFFEINE) CREAM [YBK INVESTMENT, INC]1
VANILLYL BUTYL ETHERACTIVE INGREDIENTS2ULN37C9RNANO PPC (CAFFEINE) CREAM [YBK INVESTMENT, INC]1
CAFFEINEACTIVE MOIETY3G6A5W338ENANO PPC (CAFFEINE) CREAM [YBK INVESTMENT, INC]1
VANILLYL BUTYL ETHERACTIVE MOIETYS2ULN37C9RNANO PPC (CAFFEINE) CREAM [YBK INVESTMENT, INC]1
CARNITINEINACTIVE INGREDIENTS7UI8SM58ANANO PPC (CAFFEINE) CREAM [YBK INVESTMENT, INC]1
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SNANO PPC (CAFFEINE) CREAM [YBK INVESTMENT, INC]1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1ONANO PPC (CAFFEINE) CREAM [YBK INVESTMENT, INC]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KNANO PPC (CAFFEINE) CREAM [YBK INVESTMENT, INC]1
EPIGALLOCATECHIN GALLATEINACTIVE INGREDIENTBQM438CTELNANO PPC (CAFFEINE) CREAM [YBK INVESTMENT, INC]1
GINKGO BILOBA LEAF OILINACTIVE INGREDIENTY5967KO1JHNANO PPC (CAFFEINE) CREAM [YBK INVESTMENT, INC]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXNANO PPC (CAFFEINE) CREAM [YBK INVESTMENT, INC]1
GLYCERYL STEARATE SEINACTIVE INGREDIENTFCZ5MH785INANO PPC (CAFFEINE) CREAM [YBK INVESTMENT, INC]1
HYDROGENATED SOYBEAN LECITHININACTIVE INGREDIENTH1109Z9J4NNANO PPC (CAFFEINE) CREAM [YBK INVESTMENT, INC]1
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJSNANO PPC (CAFFEINE) CREAM [YBK INVESTMENT, INC]1
MECASERMININACTIVE INGREDIENT7GR9I2683ONANO PPC (CAFFEINE) CREAM [YBK INVESTMENT, INC]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TNANO PPC (CAFFEINE) CREAM [YBK INVESTMENT, INC]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPNANO PPC (CAFFEINE) CREAM [YBK INVESTMENT, INC]1
OLIVE OILINACTIVE INGREDIENT6UYK2W1W1ENANO PPC (CAFFEINE) CREAM [YBK INVESTMENT, INC]1
PEG-100 STEARATEINACTIVE INGREDIENTYD01N1999RNANO PPC (CAFFEINE) CREAM [YBK INVESTMENT, INC]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UNANO PPC (CAFFEINE) CREAM [YBK INVESTMENT, INC]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TNANO PPC (CAFFEINE) CREAM [YBK INVESTMENT, INC]1
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4MNANO PPC (CAFFEINE) CREAM [YBK INVESTMENT, INC]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3NANO PPC (CAFFEINE) CREAM [YBK INVESTMENT, INC]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHNANO PPC (CAFFEINE) CREAM [YBK INVESTMENT, INC]1
SODIUM DESOXYCHOLATEINACTIVE INGREDIENT436LS6U35YNANO PPC (CAFFEINE) CREAM [YBK INVESTMENT, INC]1
SODIUM OLEATEINACTIVE INGREDIENT399SL044HNNANO PPC (CAFFEINE) CREAM [YBK INVESTMENT, INC]1
SORBITAN SESQUIOLEATEINACTIVE INGREDIENT0W8RRI5W5ANANO PPC (CAFFEINE) CREAM [YBK INVESTMENT, INC]1
SOYBEAN OILINACTIVE INGREDIENT241ATL177ANANO PPC (CAFFEINE) CREAM [YBK INVESTMENT, INC]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APNANO PPC (CAFFEINE) CREAM [YBK INVESTMENT, INC]1
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKNANO PPC (CAFFEINE) CREAM [YBK INVESTMENT, INC]1
waterINACTIVE INGREDIENT059QF0KO0RNANO PPC (CAFFEINE) CREAM [YBK INVESTMENT, INC]1
YELLOW WAXINACTIVE INGREDIENT2ZA36H0S2VNANO PPC (CAFFEINE) CREAM [YBK INVESTMENT, INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60709-107NANO PPC (CAFFEINE) CREAM [YBK INVESTMENT, INC]1Legacy NDC, 2 package rows20131211_96e4d5fe-f459-41f7-b446-342c12880223.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
60709-107-0160709010701250 mL in 1 TUBE250 mlHistorical
60709-107-02607090107021 in 1 CARTONHistorical