Home NDC 0536-2525 Capsaicin
Product NDC 0536-2525
11-digit product format 005362525
Labeler code 0536
Product ID 0536-2525_a8b02e2a-9971-482b-97f4-82f344bd79db
Type HUMAN OTC DRUG
Nonproprietary name Capsaicin
Dosage form CREAM
Route TOPICAL
Labeler Rugby Laboratories
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2012-03-01
Substance CAPSAICIN
Active strength .25 mg/g
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2019-12-08 06:16 UTC · source 2019-12-05 excluded product product 0536-2525 E Excluded after deficient or non-compliant submission was not corrected excluded / ndc_excluded.zip 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 0536-2525 0536-2525-25 E Excluded after deficient or non-compliant submission was not corrected excluded / ndc_excluded.zip 110d247fa046…a55b01930146…
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 Capsaicin
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CAPSAICIN .25 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination S07O44R1ZM Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 198555 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0536-2525-25 Capsaicin 1 in 1 CARTON CREAM 1 8 0536-2525-25 Capsaicin 60 g in 1 TUBE CREAM 60 8 0536-2525-25 Flexipak 1 in 1 CARTON CREAM 0.025 g in 100g 1 0536-2525-25 Flexipak 60 g in 1 TUBE CREAM 60 g 0.025 g in 100g 1
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Capsaicin ACTIVE INGREDIENT S07O44R1ZM RUGBY CAPSAICIN EXTERNAL ANALGESIC (CAPSAICIN) CREAM [RUGBY LABORATORIES, INC.] 2 CAPSAICIN ACTIVE INGREDIENT S07O44R1ZM INFLAMMATION REDUCTION PACK KIT [TMIG, INC.] 2 DICLOFENAC SODIUM ACTIVE INGREDIENT QTG126297Q INFLAMMATION REDUCTION PACK KIT [TMIG, INC.] 2 RANITIDINE HYDROCHLORIDE ACTIVE INGREDIENT BK76465IHM INFLAMMATION REDUCTION PACK KIT [TMIG, INC.] 2 Capsaicin ACTIVE MOIETY S07O44R1ZM RUGBY CAPSAICIN EXTERNAL ANALGESIC (CAPSAICIN) CREAM [RUGBY LABORATORIES, INC.] 2 CAPSAICIN ACTIVE MOIETY S07O44R1ZM INFLAMMATION REDUCTION PACK KIT [TMIG, INC.] 2 DICLOFENAC ACTIVE MOIETY 144O8QL0L1 INFLAMMATION REDUCTION PACK KIT [TMIG, INC.] 2 RANITIDINE ACTIVE MOIETY 884KT10YB7 INFLAMMATION REDUCTION PACK KIT [TMIG, INC.] 2 CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) INACTIVE INGREDIENT 71DD5V995L RUGBY CAPSAICIN EXTERNAL ANALGESIC (CAPSAICIN) CREAM [RUGBY LABORATORIES, INC.] 2 CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) INACTIVE INGREDIENT 71DD5V995L INFLAMMATION REDUCTION PACK KIT [TMIG, INC.] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U INFLAMMATION REDUCTION PACK KIT [TMIG, INC.] 2 Cetyl Acetate INACTIVE INGREDIENT 4Q43814HXS RUGBY CAPSAICIN EXTERNAL ANALGESIC (CAPSAICIN) CREAM [RUGBY LABORATORIES, INC.] 2 CETYL ACETATE INACTIVE INGREDIENT 4Q43814HXS INFLAMMATION REDUCTION PACK KIT [TMIG, INC.] 2 D&C RED NO. 30 INACTIVE INGREDIENT 2S42T2808B INFLAMMATION REDUCTION PACK KIT [TMIG, INC.] 2 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 INFLAMMATION REDUCTION PACK KIT [TMIG, INC.] 2 HYDROXYPROPYL CELLULOSE (TYPE H) INACTIVE INGREDIENT RFW2ET671P INFLAMMATION REDUCTION PACK KIT [TMIG, INC.] 2 HYPROMELLOSE 2910 (3 MPA.S) INACTIVE INGREDIENT 0VUT3PMY82 INFLAMMATION REDUCTION PACK KIT [TMIG, INC.] 2 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO INFLAMMATION REDUCTION PACK KIT [TMIG, INC.] 2 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X INFLAMMATION REDUCTION PACK KIT [TMIG, INC.] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 INFLAMMATION REDUCTION PACK KIT [TMIG, INC.] 2 Methylparaben INACTIVE INGREDIENT A2I8C7HI9T RUGBY CAPSAICIN EXTERNAL ANALGESIC (CAPSAICIN) CREAM [RUGBY LABORATORIES, INC.] 2 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T INFLAMMATION REDUCTION PACK KIT [TMIG, INC.] 2 PEPPERMINT INACTIVE INGREDIENT V95R5KMY2B INFLAMMATION REDUCTION PACK KIT [TMIG, INC.] 2 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A INFLAMMATION REDUCTION PACK KIT [TMIG, INC.] 2 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H INFLAMMATION REDUCTION PACK KIT [TMIG, INC.] 2 PPG-20 Methyl Glucose Ether Distearate INACTIVE INGREDIENT 0057334FAB RUGBY CAPSAICIN EXTERNAL ANALGESIC (CAPSAICIN) CREAM [RUGBY LABORATORIES, INC.] 2 PPG-20 METHYL GLUCOSE ETHER DISTEARATE INACTIVE INGREDIENT 0057334FAB INFLAMMATION REDUCTION PACK KIT [TMIG, INC.] 2 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 INFLAMMATION REDUCTION PACK KIT [TMIG, INC.] 2 Propylene Glycol INACTIVE INGREDIENT 6DC9Q167V3 RUGBY CAPSAICIN EXTERNAL ANALGESIC (CAPSAICIN) CREAM [RUGBY LABORATORIES, INC.] 2 Propylparaben INACTIVE INGREDIENT Z8IX2SC1OH RUGBY CAPSAICIN EXTERNAL ANALGESIC (CAPSAICIN) CREAM [RUGBY LABORATORIES, INC.] 2 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH INFLAMMATION REDUCTION PACK KIT [TMIG, INC.] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 INFLAMMATION REDUCTION PACK KIT [TMIG, INC.] 2 SODIUM ALGINATE INACTIVE INGREDIENT C269C4G2ZQ INFLAMMATION REDUCTION PACK KIT [TMIG, INC.] 2 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 INFLAMMATION REDUCTION PACK KIT [TMIG, INC.] 2 STEARETH-100 INACTIVE INGREDIENT 4OH5W9UM87 INFLAMMATION REDUCTION PACK KIT [TMIG, INC.] 2 Steareth-100 INACTIVE INGREDIENT 4OH5W9UM87 RUGBY CAPSAICIN EXTERNAL ANALGESIC (CAPSAICIN) CREAM [RUGBY LABORATORIES, INC.] 2 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP INFLAMMATION REDUCTION PACK KIT [TMIG, INC.] 2 Stearic Acid INACTIVE INGREDIENT 4ELV7Z65AP RUGBY CAPSAICIN EXTERNAL ANALGESIC (CAPSAICIN) CREAM [RUGBY LABORATORIES, INC.] 2 STEARYL ALCOHOL INACTIVE INGREDIENT 2KR89I4H1Y INFLAMMATION REDUCTION PACK KIT [TMIG, INC.] 2 Stearyl Alcohol INACTIVE INGREDIENT 2KR89I4H1Y RUGBY CAPSAICIN EXTERNAL ANALGESIC (CAPSAICIN) CREAM [RUGBY LABORATORIES, INC.] 2 TALC INACTIVE INGREDIENT 7SEV7J4R1U INFLAMMATION REDUCTION PACK KIT [TMIG, INC.] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP INFLAMMATION REDUCTION PACK KIT [TMIG, INC.] 2 TRIETHYL CITRATE INACTIVE INGREDIENT 8Z96QXD6UM INFLAMMATION REDUCTION PACK KIT [TMIG, INC.] 2 Trolamine INACTIVE INGREDIENT 9O3K93S3TK RUGBY CAPSAICIN EXTERNAL ANALGESIC (CAPSAICIN) CREAM [RUGBY LABORATORIES, INC.] 2 TROLAMINE INACTIVE INGREDIENT 9O3K93S3TK INFLAMMATION REDUCTION PACK KIT [TMIG, INC.] 2 Water INACTIVE INGREDIENT 059QF0KO0R RUGBY CAPSAICIN EXTERNAL ANALGESIC (CAPSAICIN) CREAM [RUGBY LABORATORIES, INC.] 2 WATER INACTIVE INGREDIENT 059QF0KO0R INFLAMMATION REDUCTION PACK KIT [TMIG, INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0536-2525 RUGBY CAPSAICIN EXTERNAL ANALGESIC (CAPSAICIN) CREAM [RUGBY LABORATORIES] 6 Current NDC, Legacy NDC, 2 package rows 20240214_c5915c84-84a2-46f6-9f97-0d9873e9944a.zip 0536-2525 FLEXIPAK (DICLOFENAC SODIUM, CAPSAICIN) KIT [STERLING-KNIGHT PHARMACEUTICALS, LLC] 1 Current NDC, Legacy NDC 20180127_7c14a409-88c5-4b9d-80a4-f9f80c64ebbf.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 114 of 152 · 3,029 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join TheraCare Maximum Strength Pain Relief Patch LIDOCAINE Veridian Healthcare dfaf8a77-2276-4791-e053-2a95a90a3288 2024-12-10 Warnings Exact identifier application number: M017 Methyl Salicylate METHYL SALICYLATE Alexso, Inc eef555d3-f23d-4847-93f3-fa7a06072a0f 2024-12-09 Warnings Exact identifier application number: M017 Lidocaine 4 Percent LIDOCAINE SA3, LLC 651710db-3c50-4bcf-b7cc-9ed24f663427 2024-12-09 Warnings Exact identifier application number: M017 HealthWise Pain Relief Lidocaine Patch LIDOCAINE 4% Veridian Healthcare 28db1c03-d01f-83ea-e063-6294a90aee26 2024-12-09 Warnings Exact identifier application number: M017 Joint and Muscle Pain Relief MENTHOL Allure Labs e82f99fd-c2ef-686f-e053-2a95a90a1dc9 2024-12-09 Warnings Exact identifier application number: M017 Tough Love Pain Relieving LIDOCAINE HCL Allure Labs ee8c1a2b-36ef-6fd7-e053-2a95a90a9c01 2024-12-09 Warnings Exact identifier application number: M017 Capsaicin CAPSAICIN SA3, LLC 5617e91d-e650-4a0d-8565-b8288ea41c77 2024-12-09 Warnings Exact identifier application number: M017 Medicaine Sting and Bite BENZOCAINE James Alexander Corporation 753e6cbe-31e0-4017-93d0-8b4bf5972f37 2024-12-09 Warnings Exact identifier application number: M017 AUVON Pain Relief Roll-on MENTHOL SHENZHEN YUWEN E-COMMERCE CO., LTD. df239c4d-af6a-41ca-baed-d0788782ce9f 2024-12-08 Warnings Exact identifier application number: M017 AUVON Pain Relief Roll-on LIDOCAINE SHENZHEN YUWEN E-COMMERCE CO., LTD. 8b30f623-6077-4f2e-8fa4-ce4a298953b5 2024-12-08 Warnings Exact identifier application number: M017 QC Medicated anti itch PRAMOXINE HYDROCHLORIDE, MENTHOL Chain Drug Marketing Association b5e41e3a-81df-3a63-e053-2a95a90a5839 2024-12-08 Warnings Exact identifier application number: M017 QC Lidocaine Maximum Strength LIDOCAINE HCL Chain Drug Marketing Association b5e1b1ab-8a95-2d2d-e053-2995a90aea53 2024-12-08 Warnings Exact identifier application number: M017 Capsaicin CAPSAICIN Alexso, Inc 433da27d-04fb-481a-bbb0-874bb72c806a 2024-12-06 Warnings Exact identifier application number: M017 POMG PAIN RELIEF BODY LIDOCAINE POMG LLC 28d7ac46-b27f-43bb-e063-6294a90a93ed 2024-12-06 Warnings Exact identifier application number: M017 Capsaicin 0.1 Percent CAPSAICIN Alexso, Inc 0090ca38-6433-45c4-9453-edf2788c14c6 2024-12-06 Warnings Exact identifier application number: M017 Signature Care Menthol MENTHOL 4% Safeway 27d3cb47-a6c7-5b7a-e063-6394a90a056f 2024-12-05 Warnings Exact identifier application number: M017 ITCH X BENZYL ALCOHOL/PRAMOXINE HYDROCHLORIDE BF ASCHER AND CO INC 03c16d33-8f59-0184-e054-00144ff8d46c 2024-12-05 Warnings Exact identifier application number: M017 PO First Aid Series BURN LIDOCAINE HYDROCHLORIDE Nantong Health & Beyond Hygienic Products Inc. f1c349a8-216d-4233-922e-c95329a33d1e 2024-12-05 Warnings Exact identifier application number: M017 Post Treatment Balm HYDROCORTISONE Allure Labs Inc. faa803e6-453c-4d86-85dd-5a5dcdd72d02 2024-12-05 Warnings Exact identifier application number: M017 CBD Pain Relief Cream TROLAMINE SALICYLATE Allure Labs b6b3102a-4154-2da2-e053-2995a90ae99f 2024-12-05 Warnings Exact identifier application number: M017
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0536-2525-25 00536252525 1 TUBE in 1 CARTON (0536-2525-25) / 60 g in 1 TUBE 1 tube 2012-03-01 0000-00-00 No No Current