Premier Value Instant Antiseptic Pain Relief

Product NDC
68016-821
11-digit product format
680160821
Labeler code
68016
Product ID
68016-821_0cf4e97f-18e0-5426-e063-6294a90ac4b0
Type
HUMAN OTC DRUG
Nonproprietary name
Camphor 10.8% and Phenol 4.7%
Dosage form
LIQUID
Route
TOPICAL
Labeler
Pharmacy Value Alliance LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-01-30
Substance
CAMPHOR (NATURAL); PHENOL
Active strength
108; 47 mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Premier Value Instant Antiseptic Pain Relief
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CAMPHOR (NATURAL)108 mg/mL
PHENOL47 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
N20HL7Q941Internal UNII lookup
339NCG44TVInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
308940Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9d63f8ed-fc50-0d84-e053-2a95a90a6e92Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68016-821-45Premier Value Instant Antiseptic Pain Relief45 mL in 1 BOTTLE, GLASSLIQUID453

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68016-821PREMIER VALUE INSTANT ANTISEPTIC PAIN RELIEF (CAMPHOR 10.8% AND PHENOL 4.7%) LIQUID [PHARMACY VALUE ALLIANCE LLC]3Current NDC, Legacy NDC, 1 package rows20231221_9d63f8ed-fc50-0d84-e053-2a95a90a6e92.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 41 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Maximum Strength Cortisone Cream with AloeHYDROCORTISONE CREAMCVS Pharmacyb95d30b0-6ebd-4989-a6ac-1a42e5d4aba52026-01-14WarningsExact identifier
application number: M017
Maximum Strength Hydrocortisone Cream with AloeHYDROCORTISONE CREAMWalgreens61b93226-10ff-43df-b1b6-bcea917a2f482026-01-14WarningsExact identifier
application number: M017
Maximum Strength Hydrocortisone CreamHYDROCORTISONE CREAMWalgreens2112067c-0fbb-400c-9923-b932946e1a122026-01-14WarningsExact identifier
application number: M017
Maximum Strength Hydrocortisone CreamHYDROCORTISONE CREAMWalgreensa7db0a6f-ceca-4e77-bad7-55c3c74413a72026-01-14WarningsExact identifier
application number: M017
CVS Therapeutic Menthol GelMENTHOLCVS Pharmacya02605cd-40d1-4ea1-9828-0695f2d123aa2026-01-14WarningsExact identifier
application number: M017
Maximum Strength CortisoneHYDROCORTISONE OINTMENTCVS Pharmacyf25f2e14-4fc9-4c92-880d-e5f9279d4ecd2026-01-14WarningsExact identifier
application number: M017
Icy Hot with Lidocaine No-MessMENTHOL AND LIDOCAINEChattem, Inc.a2803c07-bf39-4028-9262-5082da25b46e2026-01-14WarningsExact identifier
application number: M017
Cortisone 10 Intensive Moisture CremeHYDROCORTISONEChattem, Inc.096a9af3-7e7c-4dae-bc22-44061c60d3c92026-01-14WarningsExact identifier
application number: M017
Icy Hot DryMENTHOLChattem, Inc.720a85cc-8e98-43f2-9cc8-5636ae09624f2026-01-14WarningsExact identifier
application number: M017
Gold Bond Extra StrengthMENTHOLChattem, Inc.98ea15e6-972f-44a3-a1e4-abeae538d5a72026-01-14WarningsExact identifier
application number: M017
Timing Pain Savior Fragrant Ginger PatchMENTHOL, METHYL SALICYLATETiming Pharmaceutical Co., Ltd PABP Brancha0308e0e-1b47-42ab-88ac-b71ff3fa6c472026-01-14WarningsExact identifier
application number: M017
Cortizone 10 Easy ReliefHYDROCORTISONEChattem, Inc.beb73818-cd88-44ff-8ecd-b02b910b53b72026-01-14WarningsExact identifier
application number: M017
diphenhydramine hcl and zinc acetateDIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATEPadagis Israel Pharmaceuticals Ltd6d7a7615-9ae7-4c55-8a84-dba746f535d72026-01-14WarningsExact identifier
application number: M017
Timing Pain Savior Cool Herbal PatchMENTHOL, METHYL SALICYLATETiming Pharmaceutical Co., Ltd PABP Branch3b260be8-5e2a-4fba-85d6-2e6c64b970762026-01-14WarningsExact identifier
application number: M017
Cortizone 10 Feminine Itch ReliefHYDROCORTISONEChattem, Inc.c0c0c1fb-43c9-4903-bb3b-f0885619b8cc2026-01-14WarningsExact identifier
application number: M017
Icy Hot Pro Pain Relief Cream w/ microbeadsMENTHOL, CAMPHORChattem, Inc.df5fd485-f583-46b7-a869-16ca2e17185c2026-01-14WarningsExact identifier
application number: M017
Cortizone 10 Ultra Soothing CremeHYDROCORTISONEChattem, Inc.4b62615f-e713-42f2-8b9c-9eebf8d1b2702026-01-14WarningsExact identifier
application number: M017
Gold Bond Medicated Pain and Itch ReliefLIDOCAINE HYDROCHLORIDEChattem, Inc.5767362c-83af-494e-a815-a13f2cb093ef2026-01-14WarningsExact identifier
application number: M017
Cortizone 10 Fast Acting Itch Relief CoolingHYDROCORTISONEChattem, Inc.01cd77e3-380f-4487-ae6e-3ac45355d8a42026-01-14WarningsExact identifier
application number: M017
hydrocortisoneHYDROCORTISONEPadagis Israel Pharmaceuticals Ltd0174411c-1b10-4298-b820-87b24065b1182026-01-14WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308940camphor 10.8 % / phenol 4.7 % Topical SolutionPSN9d63f8ed-fc50-0d84-e053-2a95a90a6e923
308940camphor 108 MG/ML / phenol 47 MG/ML Topical SolutionSCD9d63f8ed-fc50-0d84-e053-2a95a90a6e923
308940camphor 10.8 % / phenol 4.7 % Topical SolutionSY9d63f8ed-fc50-0d84-e053-2a95a90a6e923

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68016-821-456801608214545 mL in 1 BOTTLE, GLASS (68016-821-45) 45 ml2020-01-300000-00-00NoNoCurrent